ResearchStudy

Description

We adapted the ResearchStudy resource to collect information about german (or with at least one study center in Germany) clinical, epidemiological or Public health studies that were uploaded in NFDI4Health' German Central Health Study Hub. Studies can be either interventional or non-interventional.

Title	Canonical
NFDI4Health PR MDS Study	https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study

References

Reference direction	Title	Path
is referenced by	NFDI4Health PR MDS Composition	Composition.subject
is referenced by	NFDI4Health PR MDS Provenance	Provenance.target
references to	NFDI4Health PR MDS Centers	ResearchStudy.site

NFDI4Health_PR_MDS_Study (ResearchStudy)	I		ResearchStudy	Element id ResearchStudy Short description Investigation to increase healthcare-related patient-independent knowledge Alternate names Clinical Trial, Study Definition A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects. Comments Need to make sure we encompass public health studies. Data type ResearchStudy Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() category-interventional-a: Cardinality: 1.., if Design.primaryDesign == 'C98388' `category.coding.where(code = 'C98388').exists() implies category.extension.extension.where(url='interventional').exists()` category-interventional-b:* Cardinality: 0..0, if Design.primaryDesign != 'C98388' `category.coding.where(code = 'C98388').exists().not() implies category.extension.extension.where(url='interventional').exists().not()` category-nonInterventional-a: Cardinality: 1.., if Design.primaryDesign == 'C142615'' `category.coding.where(code = 'C142615').exists() implies category.extension.extension.where(url='nonInterventional').exists()` category-nonInterventional-b:* Cardinality: 0..0, if Design.primaryDesign != 'C142615' `category.coding.where(code = 'C142615').exists().not() implies category.extension.extension.where(url='nonInterventional').exists().not()` study-mortalityData-a: Cardinality: 0..1, if Design.studyType.nonInterventional == ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311')) `category.extension.extension.where(url='nonInterventional').valueCoding.where(code = 'C15273' or code = 'C15208' or code = '004' or code = 'D015331' or code = '005' or code = 'C53311').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data').exists()` study-mortalityData-b: Cardinality: 0..0, if Design.studyType.nonInterventional != ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311')) `category.extension.extension.where(url='nonInterventional').valueCoding.where(code = 'C15273' or code = 'C15208' or code = '004' or 'D015331' or code = '005' or code = 'C53311').exists().not() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data').exists().not()` study-statusWhenIntervention-a: Cardinality: 0..1, if Design.primaryDesign == 'C98388' `category.coding.where(code = 'C98388').exists() implies extension.extension.where(url='statusWhenIntervention').exists()` study-statusWhenIntervention-b: Cardinality: 0..1, if Design.administrativeInformation.status == ('01' OR '02' OR '03' OR '04' OR '05') `extension.extension.where(url='status').valueCoding.where(code = '01' or code = '02' or code = '03' or code = '04' or code = '05').exists() implies extension.extension.where(url='statusWhenIntervention').exists().not()` study-statusWhenIntervention-c: Cardinality: 0..0, if Design.primaryDesign != 'C98388' `category.coding.where(code = 'C98388').exists().not() implies extension.extension.where(url='statusWhenIntervention').exists().not()` study-statusWhenIntervention-d: Cardinality: 0..0, if Design.administrativeInformation.status != ('01' OR '02' OR '03' OR '04' OR '05') `extension.extension.where(url='status').valueCoding.where(code = '01' or code = '02' or code = '03' or code = '04' or code = '05').exists().not() implies extension.extension.where(url='statusWhenIntervention').exists().not()` study-recruitmentStatusRegister-a: Cardinality: 0..1, if Resource.provenance.dataSource != '06' `Composition.extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-provenance-data-source').valueCoding.where(code='06').exists().not() implies extension.extension.where(url='recruitmentStatusRegister').exists()` study-recruitmentStatusRegister-b: Cardinality: 0..0, if Resource.provenance.dataSource == '06' `Composition.extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-provenance-data-source').valueCoding.where(code='06').exists() implies extension.extension.where(url='recruitmentStatusRegister').exists().not()` probabilityMethod-a: 0..1, if Design.sampling.method == '034' `extension.extension.where(url='method').valueCoding.where(code = '034').exists() implies extension.extension.where(url='probabilityMethod').exists()` probabilityMethod-b: 0..0, if Design.sampling.method != '034' `extension.extension.where(url='method').valueCoding.where(code = '034').exists().not() implies extension.extension.where(url='probabilityMethod').exists().not()` nonProbabilityMethod-a: 0..1, if Design.sampling.method == 'C127781' `extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists() implies extension.extension.where(url='nonProbabilityMethod').exists()` nonProbabilityMethod-b: 0..0, if Design.sampling.method != 'C127781' `extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists().not() implies extension.extension.where(url='nonProbabilityMethod').exists().not()` biosamples-a: 0.., if Design.dataSource.general == 'C70699' `extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists() implies extension.extension.where(url='biosamples').exists()` biosamples-b:* 0..0, if Design.dataSource.general != 'C70699' `extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists().not() implies extension.extension.where(url='biosamples').exists().not()` imaging-a: 0.., if Design.dataSource.general == '031' `extension.extension.where(url='general').valueCoding.where(code = '031').exists() implies extension.extension.where(url='imaging').exists()` imaging-b:* 0..0, if Design.dataSource.general != '031' `extension.extension.where(url='general').valueCoding.where(code = '031').exists().not() implies extension.extension.where(url='imaging').exists().not()` omics-a: 0.., if Design.dataSource.general == '033' `extension.extension.where(url='general').valueCoding.where(code = '033').exists() implies extension.extension.where(url='omics').exists()` omics-b:* 0..0, if Design.dataSource.general != '033' `extension.extension.where(url='general').valueCoding.where(code = '033').exists().not() implies extension.extension.where(url='omics').exists().not()` supportingInformation-a: Cardinality: 0.., if Design.dataSharingPlan.generally == '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='supportingInformation').exists()` supportingInformation-b:* Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='supportingInformation').exists().not()` timeFrame-a: Cardinality: 0.., if Design.dataSharingPlan.generally == '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='timeFrame').exists()` timeFrame-b:* Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='timeFrame').exists().not()` accessCriteria-a: Cardinality: 0.., if Design.dataSharingPlan.generally == '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='accessCriteria').exists()` accessCriteria-b:* Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='accessCriteria').exists().not()` masking-roles-a: Cardinality: 0.., if Design.interventional.masking.general == true `extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='roles').exists()` masking-roles-b:* Cardinality: 0.., if Design.interventional.masking.general == false `extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='roles').exists().not()` masking-description-a:* Cardinality: 0.., if Design.interventional.masking.general == true `extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='description').exists()` masking-description-b:* Cardinality: 0.., if Design.interventional.masking.general == false `extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='description').exists().not()` interventional-a:* Cardinality: 0..1, Design.primaryDesign == 'Interventional' `category.coding.where(code = 'C98388').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists()` interventional-a: Cardinality: 0..1, Design.primaryDesign == 'Interventional' `category.coding.where(code = 'C98388').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists()` nonInterventional-a: Cardinality: 0..1, Design.primaryDesign == 'Non-interventional' `category.coding.where(code = 'C142615').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional').exists()` nonInterventional-b: Cardinality: 0..0, Design.primaryDesign != 'Non-interventional' `category.coding.where(code = 'C142615').exists().not() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional').exists().not()` study-stageStopped-a: Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07') `extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.coding.exists()` study-stageStopped-b: Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07') `extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.coding.exists().not()` study-reasonStopped-a: Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07') `extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.text.exists()` study-reasonStopped-b: Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07') `extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.text.exists().not()` recordLinkage-a: Cardinality: 1..1, if Design.dataSharingPlan.recordLinkage == 'Yes' `extension.extension.where(url='recordLinkage').where(value=true).exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage').exists()` recordLinkage-b: Cardinality: 0..0, if Design.dataSharingPlan.recordLinkage == 'No' `extension.extension.where(url='recordLinkage').where(value=false).exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage').exists().not()` legalBasisDetails-a: Cardinality: 1..1, if RecordLinkage.legalBasis == 'True' `extension.extension.where(url='legalBasis').where(value=true).exists() implies extension.extension.where(url='legalBasisDetails').exists()` legalBasisDetails-b: Cardinality: 0..0, if RecordLinkage.legalBasis == 'False' `extension.extension.where(url='legalBasis').where(value=false).exists() implies extension.extension.where(url='legalBasisDetails').exists().not()` Mappings rim: Entity. Role, or Act BRIDG5.1: ObservationalStudyProtocolVersion; Study; StudyProtocolVersion v2: OBX rim: Observation[classCode=CLNTRL, moodCode=EVN] NFDI4Health: Design
id	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id ResearchStudy.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
language		0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
text		0..1	Narrative	There are no (further) constraints on this element Element id ResearchStudy.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id ResearchStudy.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. Data type Resource Mappings rim: N/A
extension	I	5..*	Extension	Element id ResearchStudy.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
descriptions	I	1..1	Extension(Complex)	Element id ResearchStudy.extension:descriptions Short description Descriptions Alternate names extensions, user content Definition Group of items providing information about the description(s) of the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-descriptions Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Resource.descriptions
mortalityData	I	0..1	Extension(Coding)	Element id ResearchStudy.extension:mortalityData Short description Mortality data collected? Alternate names extensions, user content Definition Indication whether mortality data are collected in the [RESOURCE]. Comments Cardinality: 0..1, if (Resource.classification.type == ('Study' OR 'Substudy') AND Design.studyType.nonInterventional == ('Longitudinal' OR 'Cohort' OR 'Case-cohort' OR 'Birth cohort' OR 'Trend' OR 'Panel')) OR Resource.classification.type == ('Registry' OR 'Secondary data source'); otherwise 0..0 Cardinality: 0..1, if (Resource.classification.type == ('C63536' OR 'C198230') AND Design.studyType.nonInterventional == ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311')) OR Resource.classification.type == ('C61393' OR '178'); otherwise 0..0 Data type Extension(Coding) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.mortalityData
administrativeInformation	I	1..1	Extension(Complex)	Element id ResearchStudy.extension:administrativeInformation Short description Administrative information Alternate names extensions, user content Definition Group of items providing administrative information about the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-admin-info Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
subject	I	1..1	Extension(Coding)	Element id ResearchStudy.extension:subject Short description Primary subject Alternate names extensions, user content Definition The primary subject addressed by the [RESOURCE], for example persons, animals or other subject types. Comments Short input help: Select one value from the list. Data type Extension(Coding) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-subject Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.subject
dataSource	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:dataSource Short description Data sources of the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about data sources from which the data of the [RESOURCE] are generated or extracted. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-source Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.dataSource
recruitment	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:recruitment Short description Outcome measures in the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about recruitment and eligibility criteria. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-recruitment-backport-r5 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
comparisonGroup	I	0..*	Extension(Complex)	Element id ResearchStudy.extension:comparisonGroup Short description Arms or groups/cohorts of the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about arms or groups/cohorts of a [RESOURCE]. Comments [Backport Extension from R5: ResearchStudy.comparisonGroup; Please note that some of the elements are not relevant for NFDI4Health. Also the DataType of 'Description' has been modified to string.] Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-comparison-group-backport-r5 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.groups
outcomes	I	0..*	Extension(Complex)	Element id ResearchStudy.extension:outcomes Short description Outcome measures Alternate names extensions, user content Definition Group of items providing information about outcome measures. Comments Additional information: The items are optional, especially for non-interventional studies. [Backport Extension from R5: ResearchStudy.outcomeMeasure; Please note that some cardinalities have been adapted and some of the elements are not relevant for NFDI4Health. We changed the DataType from description to string and added an element to capture the time frame.] Data type Extension(Complex) Extension URL http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.outcomes
assessments	I	0..*	Extension(Coding)	Element id ResearchStudy.extension:assessments Short description Additional assessments and measurements Alternate names extensions, user content Definition Any additional assessments/measurements included in the [RESOURCE]. Comments Select all that apply. Data type Extension(Coding) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-assessments Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.assessments
dataSharingPlan	I	1..1	Extension(Complex)	Element id ResearchStudy.extension:dataSharingPlan Short description Data sharing Alternate names extensions, user content Definition Group of items providing information regarding the sharing of data by the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-sharing-plan Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.dataSharingPlan
nonInterventional	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:nonInterventional Short description Non-interventional aspects of the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about specific non-interventional aspects of the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.nonInterventional
interventional	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:interventional Short description Interventional aspects of the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about specific interventional aspects of the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.interventional
groupsOfDiseases	I	1..1	Extension(Complex)	Element id ResearchStudy.extension:groupsOfDiseases Short description Groups of diseases or conditions Alternate names extensions, user content Definition Description: Group of items providing information about groups of diseases or conditions on which the data were collected in the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-groups-of-diseases Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.groupsOfDiseases
sampling	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:sampling Short description Sampling method Alternate names extensions, user content Definition Group of items providing information about the applied sampling method. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-sampling Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.sampling
recordLinkage	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:recordLinkage Short description Information about record linkage for the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information on record linkage. Comments Applies only if 1.17.26.9 Design.dataSharingPlan.recordLinkage has been answered with Yes Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: RL1 RecordLinkage
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
identifier	Σ	0..*	Identifier	Element id ResearchStudy.identifier Short description Alternative identifiers Definition Group of items providing information about identifiers (IDs) assigned to the given [RESOURCE] by another registering systems, e.g. a registry of clinical trials or a data repository. Requirements Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs w5: FiveWs.identifier BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic) rim: .identifier NFDI4Health: Resource.idsAlternative
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.identifier.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Role.code or implied by context
type	Σ	1..1	CodeableConceptBinding	Element id ResearchStudy.identifier.type Short description Type of the registry Definition Type/name of the system where the given [RESOURCE] is already registered. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data type CodeableConcept Binding Value set defining codes to specify the type of a resource identifier. NFDI4Health_VS_MDS_ID_TYPE_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.5 rim: Role.code or implied by context NFDI4Health: Resource.idsAlternative.scheme
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.identifier.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General http://www.acme.com/identifiers/patient Mappings v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	Σ	1..1	string	Element id ResearchStudy.identifier.value Short description The value that is unique Definition Identifier Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Identifier (ID) assigned to the given [RESOURCE] by another registering system, e.g. by a registry of clinical trials or a data repository. ISRCTN91495258 Mappings v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value NFDI4Health: esource.idsAlternative.identifier
period	Σ	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.identifier.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id ResearchStudy.identifier.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
title	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.title Short description Name for this study Definition A short, descriptive user-friendly label for the study. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Brief Title BRIDG5.1: No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
protocol	Σ	0..*	Reference(PlanDefinition)	There are no (further) constraints on this element Element id ResearchStudy.protocol Short description Steps followed in executing study Definition The set of steps expected to be performed as part of the execution of the study. Data type Reference(PlanDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Interventions; Arm/Intervention Cross-Reference BRIDG5.1: StudyProtocolDocumentVersionPublicTitle.name rim: .outboundRelationship[typeCode=DEFN].target
partOf	Σ	0..*	Reference(ResearchStudy)	There are no (further) constraints on this element Element id ResearchStudy.partOf Short description Part of larger study Alternate names container Definition A larger research study of which this particular study is a component or step. Requirements Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc. Data type Reference(ResearchStudy) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: CompanionStudyRelationship rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
status	Σ ?!	1..1	codeBindingFixed Value	Element id ResearchStudy.status Short description active \| administratively-completed \| approved \| closed-to-accrual \| closed-to-accrual-and-intervention \| completed \| disapproved \| in-review \| temporarily-closed-to-accrual \| temporarily-closed-to-accrual-and-intervention \| withdrawn Definition The current state of the study. Comments The item does not exist in NFDI4Health' MDS. Fixed to 'active' for all studies. Data type code Binding Codes that convey the current status of the research study. ResearchStudyStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed value active Mappings w5: FiveWs.status BRIDG5.1: StudyOverallStatus.code rim: .status
primaryPurposeType	Σ	0..1	CodeableConceptBinding	Element id ResearchStudy.primaryPurposeType Short description treatment \| prevention \| diagnostic \| supportive-care \| screening \| health-services-research \| basic-science \| device-feasibility Definition The type of study based upon the intent of the study's activities. A classification of the intent of the study. Data type CodeableConcept Binding Codes for the main intent of the study. ResearchStudyPrimaryPurposeType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyProtocolVersion.primaryPurposeTypeCode NFDI4Health: Design.primaryPurpose
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.primaryPurposeType.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.primaryPurposeType.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	CodingBinding	Element id ResearchStudy.primaryPurposeType.coding Short description Primary purpose of the [RESOURCE] Definition Specification of the main purpose of the [RESOURCE]. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Additional Information: The field is defined foremost for interventional studies. For non-interventional studies, this field may not be applicable as diverse purposes may be pursued without being able to specify a primary one. In this case, the option 'Not applicable' can be selected. \| Short Input Help: Foremost for interventional studies, please specify the primary purpose why the [RESOURCE] was conducted. For non-interventional studies, this field may be 'Not applicable' as multiple purposes may be defined as primary ones. Data type Coding Binding Value set defining codes to specify the primary purpose of a (sub-)study in a ResearchStudy resource. NFDI4Health_VS_MDS_Study_Primary_Purpose_HL7_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.primaryPurposeType.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
phase	Σ	0..1	CodeableConcept	Element id ResearchStudy.phase Short description n-a \| early-phase-1 \| phase-1 \| phase-1-phase-2 \| phase-2 \| phase-2-phase-3 \| phase-3 \| phase-4 Definition The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. Data type CodeableConcept Binding Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. ResearchStudyPhase (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Phase BRIDG5.1: StudyProtocolVersion.phaseCode NFDI4Health: Design.interventional.phase
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.phase.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.phase.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	CodingBinding	Element id ResearchStudy.phase.coding Short description Numerical phase Definition If applicable, numerical phase of the [RESOURCE]. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Short input help: Select one value from the list. Data type Coding Binding Value set defining codes to specify the phase of a (sub-)study in a ResearchStudy resource. NFDI4Health_VS_MDS_Study_Phase_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.phase.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
category	Σ	1..1	CodeableConceptBinding	Element id ResearchStudy.category Short description Is the study design non-interventional or interventional? Definition Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. Data type CodeableConcept Binding Value set defining codes for primary designs of (sub-)studies in a ResearchStudy resource. NFDI4Health_VS_MDS_Study_Primary_Design_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention BRIDG5.1: InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode NFDI4Health: Design.primaryDesign
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.category.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	1..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.category.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
studyType	I	1..1	Extension(Complex)	Element id ResearchStudy.category.extension:studyType Short description Information on specific study design Alternate names extensions, user content Definition Group of items providing information about the study design. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-type Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A NFDI4Health: Design.studyType
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.category.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.category.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
focus	Σ	0..*	CodeableConcept	Element id ResearchStudy.focus Short description Primary focus of the [RESOURCE] Definition Group of items providing information about the focus of the [RESOURCE] (e.g. medication, food, therapy, device, etc.). Data type CodeableConcept Binding Codes for medications, devices and other interventions. (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Focus of Study w5: FiveWs.what[x] BRIDG5.1: InterventionalStudyProtocol.interventionTypeCode NFDI4Health: Design.focus
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.focus.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.focus.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	1..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
codeableConcept	I	1..1	Extension(Complex)	Element id ResearchStudy.focus.coding.extension:codeableConcept Short description NFDI4Health Codeable Concept Alternate names extensions, user content Definition NFDI4Health Representation of Codeable Concept. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-codeableconcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A NFDI4Health: Design.focus.code NFDI4Health: Design.focus.classification
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	0..1	code	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	1..1	string	Element id ResearchStudy.focus.text Short description Focus area Definition Focus area of the [RESOURCE] (e.g. medication, food, therapy, device, etc.). Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Additional Information: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD, etc.) is preferred. However, also self-assigned terms are allowed. \| Short input help: Preferably, use terms from SNOMED CT (https://browser.ihtsdotools.org). Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText NFDI4Health: Design.focus.label
condition	Σ	0..*	CodeableConcept	Element id ResearchStudy.condition Short description Primary health conditions or diseases considered in the [RESOURCE] Definition Group of items providing information about primary health conditions or diseases considered in the [RESOURCE]. Data type CodeableConcept Binding Identification of the condition or diagnosis. Condition/Problem/DiagnosisCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Conditions w5: FiveWs.what[x] BRIDG5.1: StudyCondition.code NFDI4Health: Design.conditions
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.condition.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.condition.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	1..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
codeableConcept	I	1..1	Extension(Complex)	Element id ResearchStudy.condition.coding.extension:codeableConcept Short description NFDI4Health Codeable Concept Alternate names extensions, user content Definition NFDI4Health Representation of Codeable Concept. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-codeableconcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A NFDI4Health: Design.conditions.code NFDI4Health: Design.conditions.classification
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	0..1	code	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	1..1	string	Element id ResearchStudy.condition.text Short description Health condition or disease Definition The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Preferably, use terms from terminologies such as SNOMED CT. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of a health condition SARS-CoV-2 Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText NFDI4Health: Design.conditions.label
contact	Σ	0..*	ContactDetail	There are no (further) constraints on this element Element id ResearchStudy.contact Short description Contact details for the study Definition Contact details to assist a user in learning more about or engaging with the study. Data type ContactDetail Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators BRIDG5.1: PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
relatedArtifact		0..1	NFDI4Health_PR_MDS_Related_Artifact_Resource	Element id ResearchStudy.relatedArtifact Short description Related publications, datasets, study documents, web pages, etc. Definition Group of items providing information about identifiers (IDs) of the resources related to the given resource, e.g. DOIs of publications, datasets, study documents or links to web pages. Comments Short input help: If existing, you can specify identifier(s) of any related resources, e.g. DOIs of publications, datasets, study documents, links to web pages, etc. Data type NFDI4Health_PR_MDS_Related_Artifact_Resource Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Citations, Links, Available Study Data/Documents BRIDG5.1: StudyProtocolDocument, StudyProtocolDocumentVersion rim: n/a NFDI4Health: Resource.ids NFDI4Health: Resource.idsNfdi4health NFDI4Health: Resource.webpage
keyword	Σ	0..*	CodeableConcept	Element id ResearchStudy.keyword Short description Keywords Definition Group of items providing information about keywords describing the [RESOURCE]. Comments Additional information: The findability of the [RESOURCE] can be significantly increased if proper keywords are stated. Data type CodeableConcept Binding Words associated with the study that may be useful in discovery. (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Keywords BRIDG5.1: DocumentVersion.keywordCode; DocumentVersion.keywordText NFDI4Health: Resource.keywords
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.keyword.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	0..1	code	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.code.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references) Data type string
extension	I	0..*	Extension	Element id ResearchStudy.keyword.coding.code.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
code	I	0..1	Extension(uri)	Element id ResearchStudy.keyword.coding.code.extension:code Short description Code Alternate names extensions, user content Definition Codein the terminology/classification used. Comments Short input help: If known, you can provide the code from the terminology/classification used. Data type Extension(uri) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Examples Example of an URI for a SNOMED CT concept. http://snomed.info/id/840533007 Mappings rim: n/a rim: N/A NFDI4Health: Resource.keywords.code
value		0..1	System.String	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.code.value Short description Primitive value for code Definition Primitive value for code Data type System.String
display	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	1..1	string	Element id ResearchStudy.keyword.text Short description label Definition Keyword(s) describing the [RESOURCE]. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Additional information: The use of terms from established classifications/vocabularies (e.g. SNOMED CT, MeSH, UMLS) is preferred. However, also self-assigned keywords are allowed. \| Short input help: Preferably, use terms from SNOMED CT or MESH. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Keyword label SARS-CoV-2 Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText NFDI4Health: Resource.keywords.label
location	Σ	0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.location Short description Geographic region(s) for study Definition Indicates a country, state or other region where the study is taking place. Data type CodeableConcept Binding Countries and regions within which this artifact is targeted for use. Jurisdiction ValueSet (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyProtocolVersion.participatingLocationCode
description		0..1	markdown	There are no (further) constraints on this element Element id ResearchStudy.description Short description What this is study doing Definition A full description of how the study is being conducted. Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Detailed Description BRIDG5.1: StudyProtocolDocumentVersion.publicDescription
enrollment	Σ	0..*	Reference(Group)	There are no (further) constraints on this element Element id ResearchStudy.enrollment Short description Inclusion & exclusion criteria Alternate names patient Definition Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes". Comments The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource. Data type Reference(Group) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria) w5: FiveWs.subject[x] BRIDG5.1: InterventionalStudyProtocol.interventionGroupQuantity rim: .participation[typeCode=SBJ].role w5: FiveWs.subject
period	Σ	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.period Short description When the study began and ended Alternate names timing Definition Identifies the start date and the expected (or actual, depending on status) end date for the study. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Start Date (start); Study Completion Date (end) w5: FiveWs.done[x] BRIDG5.1: ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration rim: .effectiveTime
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.period.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.period.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
start	Σ I	0..1	dateTime	Element id ResearchStudy.period.start Short description Start date Definition In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date. Comments Additional information: Preferred date format: DD.MM.YYYY. \| Short input help: In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: DR.1 rim: ./low NFDI4Health: Design.administrativeInformation.startDate
end	Σ I	0..1	dateTime	Element id ResearchStudy.period.end Short description End date Definition In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date. In case of a [RESOURCE] with patients or other participants, it is the date when the last participant is examined or receives an intervention, or the date of the last participant’s last visit. Comments Additional information: Preferred date format: DD.MM.YYYY. \| Short input help: In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date. Meaning when missing If the end of the period is missing, it means that the period is ongoing Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: DR.2 rim: ./high NFDI4Health: Design.administrativeInformation.endDate
sponsor	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id ResearchStudy.sponsor Short description Organization that initiates and is legally responsible for the study Definition An organization that initiates the investigation and is legally responsible for the study. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Sponsor w5: FiveWs.actor BRIDG5.1: RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode rim: .participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
principalInvestigator	Σ	0..1	Reference(Practitioner \| PractitionerRole)	There are no (further) constraints on this element Element id ResearchStudy.principalInvestigator Short description Researcher who oversees multiple aspects of the study Definition A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation. Data type Reference(Practitioner \| PractitionerRole) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Principal Investigator w5: FiveWs.actor BRIDG5.1: StudyInvestigator
site	Σ	0..1	Reference(NFDI4Health_PR_MDS_Centers)	Element id ResearchStudy.site Short description Facility where study activities are conducted Definition A facility in which study activities are conducted. Data type Reference(NFDI4Health_PR_MDS_Centers) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Facility w5: FiveWs.where[x] BRIDG5.1: PlannedStudySite; StudySite
reasonStopped	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped Short description accrual-goal-met \| closed-due-to-toxicity \| closed-due-to-lack-of-study-progress \| temporarily-closed-per-study-design Definition A description and/or code explaining the premature termination of the study. Data type CodeableConcept Binding Codes for why the study ended prematurely. ResearchStudyReasonStopped (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Why Study Stopped w5: FiveWs.why[x] BRIDG5.1: StudyOverallStatus.studyStoppedReasonCode
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..1	CodingBinding	Element id ResearchStudy.reasonStopped.coding Short description Stopping stage Definition Specification of the stage at which the [RESOURCE] was prematurely stopped. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.administrativeInformation.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); otherwise 0..0 / Short Input Help: Select one value from the list. / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Study_Status_Halted_Stage_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding NFDI4Health: Design.administrativeInformation.stageStopped
text	Σ	0..1	string	Element id ResearchStudy.reasonStopped.text Short description Stopping reason Definition Specification of the reasons why the [RESOURCE] was prematurely stopped, for example due to toxicity, closed due to lack of study progress, temporarily closed per study design. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.administrativeInformation.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); otherwise 0..0 / Short Input Help: You can provide reasons such as closed due to toxicity, closed due to lack of [RESOURCE] progress, temporarily-closed per [RESOURCE] design, etc. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText NFDI4Health: Design.administrativeInformation.reasonStopped
note		0..1	Annotation	There are no (further) constraints on this element Element id ResearchStudy.note Short description Comments made about the study Definition Comments made about the study by the performer, subject or other participants. Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: No BRIDG mapping rim: .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.note.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.note.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
author[x]	Σ	0..1		There are no (further) constraints on this element Element id ResearchStudy.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation. Comments Organization is used when there's no need for specific attribution as to who made the comment. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Act.participant[typeCode=AUT].role
authorString			string	There are no (further) constraints on this element Data type string
authorReference			Reference(Practitioner \| Patient \| RelatedPerson \| Organization)	There are no (further) constraints on this element Data type Reference(Practitioner \| Patient \| RelatedPerson \| Organization)
time	Σ	0..1	dateTime	There are no (further) constraints on this element Element id ResearchStudy.note.time Short description When the annotation was made Definition Indicates when this particular annotation was made. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Act.effectiveTime
text	Σ	1..1	markdown	Element id ResearchStudy.note.text Short description Additional information about the [RESOURCE] Definition Any additional information about specific aspects of the [RESOURCE] that could not be captured by other fields.. Comments Short input help: You can provide here specific aspects of the [RESOURCE] that could not be captured by other fields. Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Act.text NFDI4Health: Design.comment
arm		0..*	BackboneElement	There are no (further) constraints on this element Element id ResearchStudy.arm Short description Defined path through the study for a subject Definition Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arms BRIDG5.1: Arm
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.arm.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.arm.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
name		1..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.name Short description Label for study arm Definition Unique, human-readable label for this arm of the study. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Label BRIDG5.1: Arm.name
type		0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.arm.type Short description Categorization of study arm Definition Categorization of study arm, e.g. experimental, active comparator, placebo comparater. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Type BRIDG5.1: Arm.typeCode
description		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.description Short description Short explanation of study path Definition A succinct description of the path through the study that would be followed by a subject adhering to this arm. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Description BRIDG5.1: Arm.description
objective		0..*	BackboneElement	There are no (further) constraints on this element Element id ResearchStudy.objective Short description A goal for the study Definition A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyObjective
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.objective.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.objective.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.objective.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
name		1..1	string	Element id ResearchStudy.objective.name Short description Research questions/hypotheses Definition Statement of the research questions and/or hypotheses underlying the [RESOURCE]. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: No BRIDG mapping (BRIDG has a description, but not a name) NFDI4Health: Design.hypotheses
type		0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.objective.type Short description primary \| secondary \| exploratory Definition The kind of study objective. Data type CodeableConcept Binding Codes for the kind of study objective. ResearchStudyObjectiveType (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyObjective.typeCode

NFDI4Health_PR_MDS_Study (ResearchStudy)	I		ResearchStudy	Element id ResearchStudy Short description Investigation to increase healthcare-related patient-independent knowledge Alternate names Clinical Trial, Study Definition A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects. Comments Need to make sure we encompass public health studies. Data type ResearchStudy Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() category-interventional-a: Cardinality: 1.., if Design.primaryDesign == 'C98388' `category.coding.where(code = 'C98388').exists() implies category.extension.extension.where(url='interventional').exists()` category-interventional-b:* Cardinality: 0..0, if Design.primaryDesign != 'C98388' `category.coding.where(code = 'C98388').exists().not() implies category.extension.extension.where(url='interventional').exists().not()` category-nonInterventional-a: Cardinality: 1.., if Design.primaryDesign == 'C142615'' `category.coding.where(code = 'C142615').exists() implies category.extension.extension.where(url='nonInterventional').exists()` category-nonInterventional-b:* Cardinality: 0..0, if Design.primaryDesign != 'C142615' `category.coding.where(code = 'C142615').exists().not() implies category.extension.extension.where(url='nonInterventional').exists().not()` study-mortalityData-a: Cardinality: 0..1, if Design.studyType.nonInterventional == ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311')) `category.extension.extension.where(url='nonInterventional').valueCoding.where(code = 'C15273' or code = 'C15208' or code = '004' or code = 'D015331' or code = '005' or code = 'C53311').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data').exists()` study-mortalityData-b: Cardinality: 0..0, if Design.studyType.nonInterventional != ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311')) `category.extension.extension.where(url='nonInterventional').valueCoding.where(code = 'C15273' or code = 'C15208' or code = '004' or 'D015331' or code = '005' or code = 'C53311').exists().not() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data').exists().not()` study-statusWhenIntervention-a: Cardinality: 0..1, if Design.primaryDesign == 'C98388' `category.coding.where(code = 'C98388').exists() implies extension.extension.where(url='statusWhenIntervention').exists()` study-statusWhenIntervention-b: Cardinality: 0..1, if Design.administrativeInformation.status == ('01' OR '02' OR '03' OR '04' OR '05') `extension.extension.where(url='status').valueCoding.where(code = '01' or code = '02' or code = '03' or code = '04' or code = '05').exists() implies extension.extension.where(url='statusWhenIntervention').exists().not()` study-statusWhenIntervention-c: Cardinality: 0..0, if Design.primaryDesign != 'C98388' `category.coding.where(code = 'C98388').exists().not() implies extension.extension.where(url='statusWhenIntervention').exists().not()` study-statusWhenIntervention-d: Cardinality: 0..0, if Design.administrativeInformation.status != ('01' OR '02' OR '03' OR '04' OR '05') `extension.extension.where(url='status').valueCoding.where(code = '01' or code = '02' or code = '03' or code = '04' or code = '05').exists().not() implies extension.extension.where(url='statusWhenIntervention').exists().not()` study-recruitmentStatusRegister-a: Cardinality: 0..1, if Resource.provenance.dataSource != '06' `Composition.extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-provenance-data-source').valueCoding.where(code='06').exists().not() implies extension.extension.where(url='recruitmentStatusRegister').exists()` study-recruitmentStatusRegister-b: Cardinality: 0..0, if Resource.provenance.dataSource == '06' `Composition.extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-provenance-data-source').valueCoding.where(code='06').exists() implies extension.extension.where(url='recruitmentStatusRegister').exists().not()` probabilityMethod-a: 0..1, if Design.sampling.method == '034' `extension.extension.where(url='method').valueCoding.where(code = '034').exists() implies extension.extension.where(url='probabilityMethod').exists()` probabilityMethod-b: 0..0, if Design.sampling.method != '034' `extension.extension.where(url='method').valueCoding.where(code = '034').exists().not() implies extension.extension.where(url='probabilityMethod').exists().not()` nonProbabilityMethod-a: 0..1, if Design.sampling.method == 'C127781' `extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists() implies extension.extension.where(url='nonProbabilityMethod').exists()` nonProbabilityMethod-b: 0..0, if Design.sampling.method != 'C127781' `extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists().not() implies extension.extension.where(url='nonProbabilityMethod').exists().not()` biosamples-a: 0.., if Design.dataSource.general == 'C70699' `extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists() implies extension.extension.where(url='biosamples').exists()` biosamples-b:* 0..0, if Design.dataSource.general != 'C70699' `extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists().not() implies extension.extension.where(url='biosamples').exists().not()` imaging-a: 0.., if Design.dataSource.general == '031' `extension.extension.where(url='general').valueCoding.where(code = '031').exists() implies extension.extension.where(url='imaging').exists()` imaging-b:* 0..0, if Design.dataSource.general != '031' `extension.extension.where(url='general').valueCoding.where(code = '031').exists().not() implies extension.extension.where(url='imaging').exists().not()` omics-a: 0.., if Design.dataSource.general == '033' `extension.extension.where(url='general').valueCoding.where(code = '033').exists() implies extension.extension.where(url='omics').exists()` omics-b:* 0..0, if Design.dataSource.general != '033' `extension.extension.where(url='general').valueCoding.where(code = '033').exists().not() implies extension.extension.where(url='omics').exists().not()` supportingInformation-a: Cardinality: 0.., if Design.dataSharingPlan.generally == '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='supportingInformation').exists()` supportingInformation-b:* Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='supportingInformation').exists().not()` timeFrame-a: Cardinality: 0.., if Design.dataSharingPlan.generally == '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='timeFrame').exists()` timeFrame-b:* Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='timeFrame').exists().not()` accessCriteria-a: Cardinality: 0.., if Design.dataSharingPlan.generally == '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='accessCriteria').exists()` accessCriteria-b:* Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='accessCriteria').exists().not()` masking-roles-a: Cardinality: 0.., if Design.interventional.masking.general == true `extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='roles').exists()` masking-roles-b:* Cardinality: 0.., if Design.interventional.masking.general == false `extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='roles').exists().not()` masking-description-a:* Cardinality: 0.., if Design.interventional.masking.general == true `extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='description').exists()` masking-description-b:* Cardinality: 0.., if Design.interventional.masking.general == false `extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='description').exists().not()` interventional-a:* Cardinality: 0..1, Design.primaryDesign == 'Interventional' `category.coding.where(code = 'C98388').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists()` interventional-a: Cardinality: 0..1, Design.primaryDesign == 'Interventional' `category.coding.where(code = 'C98388').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists()` nonInterventional-a: Cardinality: 0..1, Design.primaryDesign == 'Non-interventional' `category.coding.where(code = 'C142615').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional').exists()` nonInterventional-b: Cardinality: 0..0, Design.primaryDesign != 'Non-interventional' `category.coding.where(code = 'C142615').exists().not() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional').exists().not()` study-stageStopped-a: Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07') `extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.coding.exists()` study-stageStopped-b: Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07') `extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.coding.exists().not()` study-reasonStopped-a: Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07') `extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.text.exists()` study-reasonStopped-b: Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07') `extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.text.exists().not()` recordLinkage-a: Cardinality: 1..1, if Design.dataSharingPlan.recordLinkage == 'Yes' `extension.extension.where(url='recordLinkage').where(value=true).exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage').exists()` recordLinkage-b: Cardinality: 0..0, if Design.dataSharingPlan.recordLinkage == 'No' `extension.extension.where(url='recordLinkage').where(value=false).exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage').exists().not()` legalBasisDetails-a: Cardinality: 1..1, if RecordLinkage.legalBasis == 'True' `extension.extension.where(url='legalBasis').where(value=true).exists() implies extension.extension.where(url='legalBasisDetails').exists()` legalBasisDetails-b: Cardinality: 0..0, if RecordLinkage.legalBasis == 'False' `extension.extension.where(url='legalBasis').where(value=false).exists() implies extension.extension.where(url='legalBasisDetails').exists().not()` Mappings rim: Entity. Role, or Act BRIDG5.1: ObservationalStudyProtocolVersion; Study; StudyProtocolVersion v2: OBX rim: Observation[classCode=CLNTRL, moodCode=EVN] NFDI4Health: Design
id	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id ResearchStudy.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
language		0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
text		0..1	Narrative	There are no (further) constraints on this element Element id ResearchStudy.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id ResearchStudy.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. Data type Resource Mappings rim: N/A
extension	I	5..*	Extension	Element id ResearchStudy.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
descriptions	I	1..1	Extension(Complex)	Element id ResearchStudy.extension:descriptions Short description Descriptions Alternate names extensions, user content Definition Group of items providing information about the description(s) of the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-descriptions Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Resource.descriptions
mortalityData	I	0..1	Extension(Coding)	Element id ResearchStudy.extension:mortalityData Short description Mortality data collected? Alternate names extensions, user content Definition Indication whether mortality data are collected in the [RESOURCE]. Comments Cardinality: 0..1, if (Resource.classification.type == ('Study' OR 'Substudy') AND Design.studyType.nonInterventional == ('Longitudinal' OR 'Cohort' OR 'Case-cohort' OR 'Birth cohort' OR 'Trend' OR 'Panel')) OR Resource.classification.type == ('Registry' OR 'Secondary data source'); otherwise 0..0 Cardinality: 0..1, if (Resource.classification.type == ('C63536' OR 'C198230') AND Design.studyType.nonInterventional == ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311')) OR Resource.classification.type == ('C61393' OR '178'); otherwise 0..0 Data type Extension(Coding) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.mortalityData
administrativeInformation	I	1..1	Extension(Complex)	Element id ResearchStudy.extension:administrativeInformation Short description Administrative information Alternate names extensions, user content Definition Group of items providing administrative information about the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-admin-info Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
subject	I	1..1	Extension(Coding)	Element id ResearchStudy.extension:subject Short description Primary subject Alternate names extensions, user content Definition The primary subject addressed by the [RESOURCE], for example persons, animals or other subject types. Comments Short input help: Select one value from the list. Data type Extension(Coding) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-subject Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.subject
dataSource	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:dataSource Short description Data sources of the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about data sources from which the data of the [RESOURCE] are generated or extracted. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-source Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.dataSource
recruitment	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:recruitment Short description Outcome measures in the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about recruitment and eligibility criteria. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-recruitment-backport-r5 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
comparisonGroup	I	0..*	Extension(Complex)	Element id ResearchStudy.extension:comparisonGroup Short description Arms or groups/cohorts of the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about arms or groups/cohorts of a [RESOURCE]. Comments [Backport Extension from R5: ResearchStudy.comparisonGroup; Please note that some of the elements are not relevant for NFDI4Health. Also the DataType of 'Description' has been modified to string.] Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-comparison-group-backport-r5 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.groups
outcomes	I	0..*	Extension(Complex)	Element id ResearchStudy.extension:outcomes Short description Outcome measures Alternate names extensions, user content Definition Group of items providing information about outcome measures. Comments Additional information: The items are optional, especially for non-interventional studies. [Backport Extension from R5: ResearchStudy.outcomeMeasure; Please note that some cardinalities have been adapted and some of the elements are not relevant for NFDI4Health. We changed the DataType from description to string and added an element to capture the time frame.] Data type Extension(Complex) Extension URL http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.outcomes
assessments	I	0..*	Extension(Coding)	Element id ResearchStudy.extension:assessments Short description Additional assessments and measurements Alternate names extensions, user content Definition Any additional assessments/measurements included in the [RESOURCE]. Comments Select all that apply. Data type Extension(Coding) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-assessments Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.assessments
dataSharingPlan	I	1..1	Extension(Complex)	Element id ResearchStudy.extension:dataSharingPlan Short description Data sharing Alternate names extensions, user content Definition Group of items providing information regarding the sharing of data by the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-sharing-plan Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.dataSharingPlan
nonInterventional	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:nonInterventional Short description Non-interventional aspects of the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about specific non-interventional aspects of the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.nonInterventional
interventional	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:interventional Short description Interventional aspects of the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about specific interventional aspects of the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.interventional
groupsOfDiseases	I	1..1	Extension(Complex)	Element id ResearchStudy.extension:groupsOfDiseases Short description Groups of diseases or conditions Alternate names extensions, user content Definition Description: Group of items providing information about groups of diseases or conditions on which the data were collected in the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-groups-of-diseases Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.groupsOfDiseases
sampling	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:sampling Short description Sampling method Alternate names extensions, user content Definition Group of items providing information about the applied sampling method. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-sampling Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.sampling
recordLinkage	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:recordLinkage Short description Information about record linkage for the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information on record linkage. Comments Applies only if 1.17.26.9 Design.dataSharingPlan.recordLinkage has been answered with Yes Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: RL1 RecordLinkage
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
identifier	Σ	0..*	Identifier	Element id ResearchStudy.identifier Short description Alternative identifiers Definition Group of items providing information about identifiers (IDs) assigned to the given [RESOURCE] by another registering systems, e.g. a registry of clinical trials or a data repository. Requirements Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs w5: FiveWs.identifier BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic) rim: .identifier NFDI4Health: Resource.idsAlternative
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.identifier.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Role.code or implied by context
type	Σ	1..1	CodeableConceptBinding	Element id ResearchStudy.identifier.type Short description Type of the registry Definition Type/name of the system where the given [RESOURCE] is already registered. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data type CodeableConcept Binding Value set defining codes to specify the type of a resource identifier. NFDI4Health_VS_MDS_ID_TYPE_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.5 rim: Role.code or implied by context NFDI4Health: Resource.idsAlternative.scheme
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.identifier.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General http://www.acme.com/identifiers/patient Mappings v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	Σ	1..1	string	Element id ResearchStudy.identifier.value Short description The value that is unique Definition Identifier Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Identifier (ID) assigned to the given [RESOURCE] by another registering system, e.g. by a registry of clinical trials or a data repository. ISRCTN91495258 Mappings v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value NFDI4Health: esource.idsAlternative.identifier
period	Σ	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.identifier.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id ResearchStudy.identifier.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
title	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.title Short description Name for this study Definition A short, descriptive user-friendly label for the study. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Brief Title BRIDG5.1: No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
protocol	Σ	0..*	Reference(PlanDefinition)	There are no (further) constraints on this element Element id ResearchStudy.protocol Short description Steps followed in executing study Definition The set of steps expected to be performed as part of the execution of the study. Data type Reference(PlanDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Interventions; Arm/Intervention Cross-Reference BRIDG5.1: StudyProtocolDocumentVersionPublicTitle.name rim: .outboundRelationship[typeCode=DEFN].target
partOf	Σ	0..*	Reference(ResearchStudy)	There are no (further) constraints on this element Element id ResearchStudy.partOf Short description Part of larger study Alternate names container Definition A larger research study of which this particular study is a component or step. Requirements Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc. Data type Reference(ResearchStudy) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: CompanionStudyRelationship rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
status	Σ ?!	1..1	codeBindingFixed Value	Element id ResearchStudy.status Short description active \| administratively-completed \| approved \| closed-to-accrual \| closed-to-accrual-and-intervention \| completed \| disapproved \| in-review \| temporarily-closed-to-accrual \| temporarily-closed-to-accrual-and-intervention \| withdrawn Definition The current state of the study. Comments The item does not exist in NFDI4Health' MDS. Fixed to 'active' for all studies. Data type code Binding Codes that convey the current status of the research study. ResearchStudyStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed value active Mappings w5: FiveWs.status BRIDG5.1: StudyOverallStatus.code rim: .status
primaryPurposeType	Σ	0..1	CodeableConceptBinding	Element id ResearchStudy.primaryPurposeType Short description treatment \| prevention \| diagnostic \| supportive-care \| screening \| health-services-research \| basic-science \| device-feasibility Definition The type of study based upon the intent of the study's activities. A classification of the intent of the study. Data type CodeableConcept Binding Codes for the main intent of the study. ResearchStudyPrimaryPurposeType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyProtocolVersion.primaryPurposeTypeCode NFDI4Health: Design.primaryPurpose
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.primaryPurposeType.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.primaryPurposeType.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	CodingBinding	Element id ResearchStudy.primaryPurposeType.coding Short description Primary purpose of the [RESOURCE] Definition Specification of the main purpose of the [RESOURCE]. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Additional Information: The field is defined foremost for interventional studies. For non-interventional studies, this field may not be applicable as diverse purposes may be pursued without being able to specify a primary one. In this case, the option 'Not applicable' can be selected. \| Short Input Help: Foremost for interventional studies, please specify the primary purpose why the [RESOURCE] was conducted. For non-interventional studies, this field may be 'Not applicable' as multiple purposes may be defined as primary ones. Data type Coding Binding Value set defining codes to specify the primary purpose of a (sub-)study in a ResearchStudy resource. NFDI4Health_VS_MDS_Study_Primary_Purpose_HL7_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.primaryPurposeType.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
phase	Σ	0..1	CodeableConcept	Element id ResearchStudy.phase Short description n-a \| early-phase-1 \| phase-1 \| phase-1-phase-2 \| phase-2 \| phase-2-phase-3 \| phase-3 \| phase-4 Definition The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. Data type CodeableConcept Binding Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. ResearchStudyPhase (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Phase BRIDG5.1: StudyProtocolVersion.phaseCode NFDI4Health: Design.interventional.phase
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.phase.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.phase.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	CodingBinding	Element id ResearchStudy.phase.coding Short description Numerical phase Definition If applicable, numerical phase of the [RESOURCE]. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Short input help: Select one value from the list. Data type Coding Binding Value set defining codes to specify the phase of a (sub-)study in a ResearchStudy resource. NFDI4Health_VS_MDS_Study_Phase_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.phase.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
category	Σ	1..1	CodeableConceptBinding	Element id ResearchStudy.category Short description Is the study design non-interventional or interventional? Definition Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. Data type CodeableConcept Binding Value set defining codes for primary designs of (sub-)studies in a ResearchStudy resource. NFDI4Health_VS_MDS_Study_Primary_Design_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention BRIDG5.1: InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode NFDI4Health: Design.primaryDesign
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.category.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	1..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.category.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
studyType	I	1..1	Extension(Complex)	Element id ResearchStudy.category.extension:studyType Short description Information on specific study design Alternate names extensions, user content Definition Group of items providing information about the study design. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-type Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A NFDI4Health: Design.studyType
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.category.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.category.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
focus	Σ	0..*	CodeableConcept	Element id ResearchStudy.focus Short description Primary focus of the [RESOURCE] Definition Group of items providing information about the focus of the [RESOURCE] (e.g. medication, food, therapy, device, etc.). Data type CodeableConcept Binding Codes for medications, devices and other interventions. (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Focus of Study w5: FiveWs.what[x] BRIDG5.1: InterventionalStudyProtocol.interventionTypeCode NFDI4Health: Design.focus
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.focus.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.focus.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	1..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
codeableConcept	I	1..1	Extension(Complex)	Element id ResearchStudy.focus.coding.extension:codeableConcept Short description NFDI4Health Codeable Concept Alternate names extensions, user content Definition NFDI4Health Representation of Codeable Concept. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-codeableconcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A NFDI4Health: Design.focus.code NFDI4Health: Design.focus.classification
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	0..1	code	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	1..1	string	Element id ResearchStudy.focus.text Short description Focus area Definition Focus area of the [RESOURCE] (e.g. medication, food, therapy, device, etc.). Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Additional Information: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD, etc.) is preferred. However, also self-assigned terms are allowed. \| Short input help: Preferably, use terms from SNOMED CT (https://browser.ihtsdotools.org). Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText NFDI4Health: Design.focus.label
condition	Σ	0..*	CodeableConcept	Element id ResearchStudy.condition Short description Primary health conditions or diseases considered in the [RESOURCE] Definition Group of items providing information about primary health conditions or diseases considered in the [RESOURCE]. Data type CodeableConcept Binding Identification of the condition or diagnosis. Condition/Problem/DiagnosisCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Conditions w5: FiveWs.what[x] BRIDG5.1: StudyCondition.code NFDI4Health: Design.conditions
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.condition.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.condition.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	1..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
codeableConcept	I	1..1	Extension(Complex)	Element id ResearchStudy.condition.coding.extension:codeableConcept Short description NFDI4Health Codeable Concept Alternate names extensions, user content Definition NFDI4Health Representation of Codeable Concept. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-codeableconcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A NFDI4Health: Design.conditions.code NFDI4Health: Design.conditions.classification
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	0..1	code	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	1..1	string	Element id ResearchStudy.condition.text Short description Health condition or disease Definition The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Preferably, use terms from terminologies such as SNOMED CT. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of a health condition SARS-CoV-2 Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText NFDI4Health: Design.conditions.label
contact	Σ	0..*	ContactDetail	There are no (further) constraints on this element Element id ResearchStudy.contact Short description Contact details for the study Definition Contact details to assist a user in learning more about or engaging with the study. Data type ContactDetail Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators BRIDG5.1: PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
relatedArtifact		0..1	NFDI4Health_PR_MDS_Related_Artifact_Resource	Element id ResearchStudy.relatedArtifact Short description Related publications, datasets, study documents, web pages, etc. Definition Group of items providing information about identifiers (IDs) of the resources related to the given resource, e.g. DOIs of publications, datasets, study documents or links to web pages. Comments Short input help: If existing, you can specify identifier(s) of any related resources, e.g. DOIs of publications, datasets, study documents, links to web pages, etc. Data type NFDI4Health_PR_MDS_Related_Artifact_Resource Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Citations, Links, Available Study Data/Documents BRIDG5.1: StudyProtocolDocument, StudyProtocolDocumentVersion rim: n/a NFDI4Health: Resource.ids NFDI4Health: Resource.idsNfdi4health NFDI4Health: Resource.webpage
keyword	Σ	0..*	CodeableConcept	Element id ResearchStudy.keyword Short description Keywords Definition Group of items providing information about keywords describing the [RESOURCE]. Comments Additional information: The findability of the [RESOURCE] can be significantly increased if proper keywords are stated. Data type CodeableConcept Binding Words associated with the study that may be useful in discovery. (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Keywords BRIDG5.1: DocumentVersion.keywordCode; DocumentVersion.keywordText NFDI4Health: Resource.keywords
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.keyword.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	0..1	code	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.code.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references) Data type string
extension	I	0..*	Extension	Element id ResearchStudy.keyword.coding.code.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
code	I	0..1	Extension(uri)	Element id ResearchStudy.keyword.coding.code.extension:code Short description Code Alternate names extensions, user content Definition Codein the terminology/classification used. Comments Short input help: If known, you can provide the code from the terminology/classification used. Data type Extension(uri) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Examples Example of an URI for a SNOMED CT concept. http://snomed.info/id/840533007 Mappings rim: n/a rim: N/A NFDI4Health: Resource.keywords.code
value		0..1	System.String	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.code.value Short description Primitive value for code Definition Primitive value for code Data type System.String
display	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	1..1	string	Element id ResearchStudy.keyword.text Short description label Definition Keyword(s) describing the [RESOURCE]. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Additional information: The use of terms from established classifications/vocabularies (e.g. SNOMED CT, MeSH, UMLS) is preferred. However, also self-assigned keywords are allowed. \| Short input help: Preferably, use terms from SNOMED CT or MESH. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Keyword label SARS-CoV-2 Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText NFDI4Health: Resource.keywords.label
location	Σ	0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.location Short description Geographic region(s) for study Definition Indicates a country, state or other region where the study is taking place. Data type CodeableConcept Binding Countries and regions within which this artifact is targeted for use. Jurisdiction ValueSet (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyProtocolVersion.participatingLocationCode
description		0..1	markdown	There are no (further) constraints on this element Element id ResearchStudy.description Short description What this is study doing Definition A full description of how the study is being conducted. Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Detailed Description BRIDG5.1: StudyProtocolDocumentVersion.publicDescription
enrollment	Σ	0..*	Reference(Group)	There are no (further) constraints on this element Element id ResearchStudy.enrollment Short description Inclusion & exclusion criteria Alternate names patient Definition Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes". Comments The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource. Data type Reference(Group) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria) w5: FiveWs.subject[x] BRIDG5.1: InterventionalStudyProtocol.interventionGroupQuantity rim: .participation[typeCode=SBJ].role w5: FiveWs.subject
period	Σ	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.period Short description When the study began and ended Alternate names timing Definition Identifies the start date and the expected (or actual, depending on status) end date for the study. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Start Date (start); Study Completion Date (end) w5: FiveWs.done[x] BRIDG5.1: ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration rim: .effectiveTime
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.period.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.period.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
start	Σ I	0..1	dateTime	Element id ResearchStudy.period.start Short description Start date Definition In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date. Comments Additional information: Preferred date format: DD.MM.YYYY. \| Short input help: In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: DR.1 rim: ./low NFDI4Health: Design.administrativeInformation.startDate
end	Σ I	0..1	dateTime	Element id ResearchStudy.period.end Short description End date Definition In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date. In case of a [RESOURCE] with patients or other participants, it is the date when the last participant is examined or receives an intervention, or the date of the last participant’s last visit. Comments Additional information: Preferred date format: DD.MM.YYYY. \| Short input help: In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date. Meaning when missing If the end of the period is missing, it means that the period is ongoing Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: DR.2 rim: ./high NFDI4Health: Design.administrativeInformation.endDate
sponsor	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id ResearchStudy.sponsor Short description Organization that initiates and is legally responsible for the study Definition An organization that initiates the investigation and is legally responsible for the study. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Sponsor w5: FiveWs.actor BRIDG5.1: RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode rim: .participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
principalInvestigator	Σ	0..1	Reference(Practitioner \| PractitionerRole)	There are no (further) constraints on this element Element id ResearchStudy.principalInvestigator Short description Researcher who oversees multiple aspects of the study Definition A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation. Data type Reference(Practitioner \| PractitionerRole) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Principal Investigator w5: FiveWs.actor BRIDG5.1: StudyInvestigator
site	Σ	0..1	Reference(NFDI4Health_PR_MDS_Centers)	Element id ResearchStudy.site Short description Facility where study activities are conducted Definition A facility in which study activities are conducted. Data type Reference(NFDI4Health_PR_MDS_Centers) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Facility w5: FiveWs.where[x] BRIDG5.1: PlannedStudySite; StudySite
reasonStopped	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped Short description accrual-goal-met \| closed-due-to-toxicity \| closed-due-to-lack-of-study-progress \| temporarily-closed-per-study-design Definition A description and/or code explaining the premature termination of the study. Data type CodeableConcept Binding Codes for why the study ended prematurely. ResearchStudyReasonStopped (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Why Study Stopped w5: FiveWs.why[x] BRIDG5.1: StudyOverallStatus.studyStoppedReasonCode
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..1	CodingBinding	Element id ResearchStudy.reasonStopped.coding Short description Stopping stage Definition Specification of the stage at which the [RESOURCE] was prematurely stopped. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.administrativeInformation.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); otherwise 0..0 / Short Input Help: Select one value from the list. / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Study_Status_Halted_Stage_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding NFDI4Health: Design.administrativeInformation.stageStopped
text	Σ	0..1	string	Element id ResearchStudy.reasonStopped.text Short description Stopping reason Definition Specification of the reasons why the [RESOURCE] was prematurely stopped, for example due to toxicity, closed due to lack of study progress, temporarily closed per study design. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.administrativeInformation.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); otherwise 0..0 / Short Input Help: You can provide reasons such as closed due to toxicity, closed due to lack of [RESOURCE] progress, temporarily-closed per [RESOURCE] design, etc. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText NFDI4Health: Design.administrativeInformation.reasonStopped
note		0..1	Annotation	There are no (further) constraints on this element Element id ResearchStudy.note Short description Comments made about the study Definition Comments made about the study by the performer, subject or other participants. Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: No BRIDG mapping rim: .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.note.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.note.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
author[x]	Σ	0..1		There are no (further) constraints on this element Element id ResearchStudy.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation. Comments Organization is used when there's no need for specific attribution as to who made the comment. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Act.participant[typeCode=AUT].role
authorString			string	There are no (further) constraints on this element Data type string
authorReference			Reference(Practitioner \| Patient \| RelatedPerson \| Organization)	There are no (further) constraints on this element Data type Reference(Practitioner \| Patient \| RelatedPerson \| Organization)
time	Σ	0..1	dateTime	There are no (further) constraints on this element Element id ResearchStudy.note.time Short description When the annotation was made Definition Indicates when this particular annotation was made. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Act.effectiveTime
text	Σ	1..1	markdown	Element id ResearchStudy.note.text Short description Additional information about the [RESOURCE] Definition Any additional information about specific aspects of the [RESOURCE] that could not be captured by other fields.. Comments Short input help: You can provide here specific aspects of the [RESOURCE] that could not be captured by other fields. Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Act.text NFDI4Health: Design.comment
arm		0..*	BackboneElement	There are no (further) constraints on this element Element id ResearchStudy.arm Short description Defined path through the study for a subject Definition Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arms BRIDG5.1: Arm
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.arm.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.arm.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
name		1..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.name Short description Label for study arm Definition Unique, human-readable label for this arm of the study. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Label BRIDG5.1: Arm.name
type		0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.arm.type Short description Categorization of study arm Definition Categorization of study arm, e.g. experimental, active comparator, placebo comparater. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Type BRIDG5.1: Arm.typeCode
description		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.description Short description Short explanation of study path Definition A succinct description of the path through the study that would be followed by a subject adhering to this arm. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Description BRIDG5.1: Arm.description
objective		0..*	BackboneElement	There are no (further) constraints on this element Element id ResearchStudy.objective Short description A goal for the study Definition A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyObjective
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.objective.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.objective.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.objective.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
name		1..1	string	Element id ResearchStudy.objective.name Short description Research questions/hypotheses Definition Statement of the research questions and/or hypotheses underlying the [RESOURCE]. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: No BRIDG mapping (BRIDG has a description, but not a name) NFDI4Health: Design.hypotheses
type		0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.objective.type Short description primary \| secondary \| exploratory Definition The kind of study objective. Data type CodeableConcept Binding Codes for the kind of study objective. ResearchStudyObjectiveType (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyObjective.typeCode

NFDI4Health_PR_MDS_Study (ResearchStudy)	I		ResearchStudy	Element id ResearchStudy Short description Investigation to increase healthcare-related patient-independent knowledge Alternate names Clinical Trial, Study Definition A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects. Comments Need to make sure we encompass public health studies. Data type ResearchStudy Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() category-interventional-a: Cardinality: 1.., if Design.primaryDesign == 'C98388' `category.coding.where(code = 'C98388').exists() implies category.extension.extension.where(url='interventional').exists()` category-interventional-b:* Cardinality: 0..0, if Design.primaryDesign != 'C98388' `category.coding.where(code = 'C98388').exists().not() implies category.extension.extension.where(url='interventional').exists().not()` category-nonInterventional-a: Cardinality: 1.., if Design.primaryDesign == 'C142615'' `category.coding.where(code = 'C142615').exists() implies category.extension.extension.where(url='nonInterventional').exists()` category-nonInterventional-b:* Cardinality: 0..0, if Design.primaryDesign != 'C142615' `category.coding.where(code = 'C142615').exists().not() implies category.extension.extension.where(url='nonInterventional').exists().not()` study-mortalityData-a: Cardinality: 0..1, if Design.studyType.nonInterventional == ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311')) `category.extension.extension.where(url='nonInterventional').valueCoding.where(code = 'C15273' or code = 'C15208' or code = '004' or code = 'D015331' or code = '005' or code = 'C53311').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data').exists()` study-mortalityData-b: Cardinality: 0..0, if Design.studyType.nonInterventional != ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311')) `category.extension.extension.where(url='nonInterventional').valueCoding.where(code = 'C15273' or code = 'C15208' or code = '004' or 'D015331' or code = '005' or code = 'C53311').exists().not() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data').exists().not()` study-statusWhenIntervention-a: Cardinality: 0..1, if Design.primaryDesign == 'C98388' `category.coding.where(code = 'C98388').exists() implies extension.extension.where(url='statusWhenIntervention').exists()` study-statusWhenIntervention-b: Cardinality: 0..1, if Design.administrativeInformation.status == ('01' OR '02' OR '03' OR '04' OR '05') `extension.extension.where(url='status').valueCoding.where(code = '01' or code = '02' or code = '03' or code = '04' or code = '05').exists() implies extension.extension.where(url='statusWhenIntervention').exists().not()` study-statusWhenIntervention-c: Cardinality: 0..0, if Design.primaryDesign != 'C98388' `category.coding.where(code = 'C98388').exists().not() implies extension.extension.where(url='statusWhenIntervention').exists().not()` study-statusWhenIntervention-d: Cardinality: 0..0, if Design.administrativeInformation.status != ('01' OR '02' OR '03' OR '04' OR '05') `extension.extension.where(url='status').valueCoding.where(code = '01' or code = '02' or code = '03' or code = '04' or code = '05').exists().not() implies extension.extension.where(url='statusWhenIntervention').exists().not()` study-recruitmentStatusRegister-a: Cardinality: 0..1, if Resource.provenance.dataSource != '06' `Composition.extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-provenance-data-source').valueCoding.where(code='06').exists().not() implies extension.extension.where(url='recruitmentStatusRegister').exists()` study-recruitmentStatusRegister-b: Cardinality: 0..0, if Resource.provenance.dataSource == '06' `Composition.extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-provenance-data-source').valueCoding.where(code='06').exists() implies extension.extension.where(url='recruitmentStatusRegister').exists().not()` probabilityMethod-a: 0..1, if Design.sampling.method == '034' `extension.extension.where(url='method').valueCoding.where(code = '034').exists() implies extension.extension.where(url='probabilityMethod').exists()` probabilityMethod-b: 0..0, if Design.sampling.method != '034' `extension.extension.where(url='method').valueCoding.where(code = '034').exists().not() implies extension.extension.where(url='probabilityMethod').exists().not()` nonProbabilityMethod-a: 0..1, if Design.sampling.method == 'C127781' `extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists() implies extension.extension.where(url='nonProbabilityMethod').exists()` nonProbabilityMethod-b: 0..0, if Design.sampling.method != 'C127781' `extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists().not() implies extension.extension.where(url='nonProbabilityMethod').exists().not()` biosamples-a: 0.., if Design.dataSource.general == 'C70699' `extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists() implies extension.extension.where(url='biosamples').exists()` biosamples-b:* 0..0, if Design.dataSource.general != 'C70699' `extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists().not() implies extension.extension.where(url='biosamples').exists().not()` imaging-a: 0.., if Design.dataSource.general == '031' `extension.extension.where(url='general').valueCoding.where(code = '031').exists() implies extension.extension.where(url='imaging').exists()` imaging-b:* 0..0, if Design.dataSource.general != '031' `extension.extension.where(url='general').valueCoding.where(code = '031').exists().not() implies extension.extension.where(url='imaging').exists().not()` omics-a: 0.., if Design.dataSource.general == '033' `extension.extension.where(url='general').valueCoding.where(code = '033').exists() implies extension.extension.where(url='omics').exists()` omics-b:* 0..0, if Design.dataSource.general != '033' `extension.extension.where(url='general').valueCoding.where(code = '033').exists().not() implies extension.extension.where(url='omics').exists().not()` supportingInformation-a: Cardinality: 0.., if Design.dataSharingPlan.generally == '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='supportingInformation').exists()` supportingInformation-b:* Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='supportingInformation').exists().not()` timeFrame-a: Cardinality: 0.., if Design.dataSharingPlan.generally == '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='timeFrame').exists()` timeFrame-b:* Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='timeFrame').exists().not()` accessCriteria-a: Cardinality: 0.., if Design.dataSharingPlan.generally == '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='accessCriteria').exists()` accessCriteria-b:* Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001' `extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='accessCriteria').exists().not()` masking-roles-a: Cardinality: 0.., if Design.interventional.masking.general == true `extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='roles').exists()` masking-roles-b:* Cardinality: 0.., if Design.interventional.masking.general == false `extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='roles').exists().not()` masking-description-a:* Cardinality: 0.., if Design.interventional.masking.general == true `extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='description').exists()` masking-description-b:* Cardinality: 0.., if Design.interventional.masking.general == false `extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='description').exists().not()` interventional-a:* Cardinality: 0..1, Design.primaryDesign == 'Interventional' `category.coding.where(code = 'C98388').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists()` interventional-a: Cardinality: 0..1, Design.primaryDesign == 'Interventional' `category.coding.where(code = 'C98388').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists()` nonInterventional-a: Cardinality: 0..1, Design.primaryDesign == 'Non-interventional' `category.coding.where(code = 'C142615').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional').exists()` nonInterventional-b: Cardinality: 0..0, Design.primaryDesign != 'Non-interventional' `category.coding.where(code = 'C142615').exists().not() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional').exists().not()` study-stageStopped-a: Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07') `extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.coding.exists()` study-stageStopped-b: Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07') `extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.coding.exists().not()` study-reasonStopped-a: Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07') `extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.text.exists()` study-reasonStopped-b: Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07') `extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.text.exists().not()` recordLinkage-a: Cardinality: 1..1, if Design.dataSharingPlan.recordLinkage == 'Yes' `extension.extension.where(url='recordLinkage').where(value=true).exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage').exists()` recordLinkage-b: Cardinality: 0..0, if Design.dataSharingPlan.recordLinkage == 'No' `extension.extension.where(url='recordLinkage').where(value=false).exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage').exists().not()` legalBasisDetails-a: Cardinality: 1..1, if RecordLinkage.legalBasis == 'True' `extension.extension.where(url='legalBasis').where(value=true).exists() implies extension.extension.where(url='legalBasisDetails').exists()` legalBasisDetails-b: Cardinality: 0..0, if RecordLinkage.legalBasis == 'False' `extension.extension.where(url='legalBasis').where(value=false).exists() implies extension.extension.where(url='legalBasisDetails').exists().not()` Mappings rim: Entity. Role, or Act BRIDG5.1: ObservationalStudyProtocolVersion; Study; StudyProtocolVersion v2: OBX rim: Observation[classCode=CLNTRL, moodCode=EVN] NFDI4Health: Design
id	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id ResearchStudy.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
language		0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
text		0..1	Narrative	There are no (further) constraints on this element Element id ResearchStudy.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id ResearchStudy.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. Data type Resource Mappings rim: N/A
extension	I	5..*	Extension	Element id ResearchStudy.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
descriptions	I	1..1	Extension(Complex)	Element id ResearchStudy.extension:descriptions Short description Descriptions Alternate names extensions, user content Definition Group of items providing information about the description(s) of the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-descriptions Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Resource.descriptions
mortalityData	I	0..1	Extension(Coding)	Element id ResearchStudy.extension:mortalityData Short description Mortality data collected? Alternate names extensions, user content Definition Indication whether mortality data are collected in the [RESOURCE]. Comments Cardinality: 0..1, if (Resource.classification.type == ('Study' OR 'Substudy') AND Design.studyType.nonInterventional == ('Longitudinal' OR 'Cohort' OR 'Case-cohort' OR 'Birth cohort' OR 'Trend' OR 'Panel')) OR Resource.classification.type == ('Registry' OR 'Secondary data source'); otherwise 0..0 Cardinality: 0..1, if (Resource.classification.type == ('C63536' OR 'C198230') AND Design.studyType.nonInterventional == ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311')) OR Resource.classification.type == ('C61393' OR '178'); otherwise 0..0 Data type Extension(Coding) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.mortalityData
administrativeInformation	I	1..1	Extension(Complex)	Element id ResearchStudy.extension:administrativeInformation Short description Administrative information Alternate names extensions, user content Definition Group of items providing administrative information about the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-admin-info Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
subject	I	1..1	Extension(Coding)	Element id ResearchStudy.extension:subject Short description Primary subject Alternate names extensions, user content Definition The primary subject addressed by the [RESOURCE], for example persons, animals or other subject types. Comments Short input help: Select one value from the list. Data type Extension(Coding) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-subject Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.subject
dataSource	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:dataSource Short description Data sources of the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about data sources from which the data of the [RESOURCE] are generated or extracted. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-source Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.dataSource
recruitment	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:recruitment Short description Outcome measures in the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about recruitment and eligibility criteria. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-recruitment-backport-r5 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
comparisonGroup	I	0..*	Extension(Complex)	Element id ResearchStudy.extension:comparisonGroup Short description Arms or groups/cohorts of the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about arms or groups/cohorts of a [RESOURCE]. Comments [Backport Extension from R5: ResearchStudy.comparisonGroup; Please note that some of the elements are not relevant for NFDI4Health. Also the DataType of 'Description' has been modified to string.] Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-comparison-group-backport-r5 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.groups
outcomes	I	0..*	Extension(Complex)	Element id ResearchStudy.extension:outcomes Short description Outcome measures Alternate names extensions, user content Definition Group of items providing information about outcome measures. Comments Additional information: The items are optional, especially for non-interventional studies. [Backport Extension from R5: ResearchStudy.outcomeMeasure; Please note that some cardinalities have been adapted and some of the elements are not relevant for NFDI4Health. We changed the DataType from description to string and added an element to capture the time frame.] Data type Extension(Complex) Extension URL http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.outcomes
assessments	I	0..*	Extension(Coding)	Element id ResearchStudy.extension:assessments Short description Additional assessments and measurements Alternate names extensions, user content Definition Any additional assessments/measurements included in the [RESOURCE]. Comments Select all that apply. Data type Extension(Coding) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-assessments Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.assessments
dataSharingPlan	I	1..1	Extension(Complex)	Element id ResearchStudy.extension:dataSharingPlan Short description Data sharing Alternate names extensions, user content Definition Group of items providing information regarding the sharing of data by the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-sharing-plan Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.dataSharingPlan
nonInterventional	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:nonInterventional Short description Non-interventional aspects of the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about specific non-interventional aspects of the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.nonInterventional
interventional	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:interventional Short description Interventional aspects of the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information about specific interventional aspects of the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.interventional
groupsOfDiseases	I	1..1	Extension(Complex)	Element id ResearchStudy.extension:groupsOfDiseases Short description Groups of diseases or conditions Alternate names extensions, user content Definition Description: Group of items providing information about groups of diseases or conditions on which the data were collected in the [RESOURCE]. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-groups-of-diseases Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.groupsOfDiseases
sampling	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:sampling Short description Sampling method Alternate names extensions, user content Definition Group of items providing information about the applied sampling method. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-sampling Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: Design.sampling
recordLinkage	I	0..1	Extension(Complex)	Element id ResearchStudy.extension:recordLinkage Short description Information about record linkage for the [RESOURCE] Alternate names extensions, user content Definition Group of items providing information on record linkage. Comments Applies only if 1.17.26.9 Design.dataSharingPlan.recordLinkage has been answered with Yes Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a NFDI4Health: RL1 RecordLinkage
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
identifier	Σ	0..*	Identifier	Element id ResearchStudy.identifier Short description Alternative identifiers Definition Group of items providing information about identifiers (IDs) assigned to the given [RESOURCE] by another registering systems, e.g. a registry of clinical trials or a data repository. Requirements Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs w5: FiveWs.identifier BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic) rim: .identifier NFDI4Health: Resource.idsAlternative
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.identifier.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Role.code or implied by context
type	Σ	1..1	CodeableConceptBinding	Element id ResearchStudy.identifier.type Short description Type of the registry Definition Type/name of the system where the given [RESOURCE] is already registered. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data type CodeableConcept Binding Value set defining codes to specify the type of a resource identifier. NFDI4Health_VS_MDS_ID_TYPE_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.5 rim: Role.code or implied by context NFDI4Health: Resource.idsAlternative.scheme
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.identifier.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General http://www.acme.com/identifiers/patient Mappings v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	Σ	1..1	string	Element id ResearchStudy.identifier.value Short description The value that is unique Definition Identifier Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Identifier (ID) assigned to the given [RESOURCE] by another registering system, e.g. by a registry of clinical trials or a data repository. ISRCTN91495258 Mappings v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value NFDI4Health: esource.idsAlternative.identifier
period	Σ	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.identifier.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id ResearchStudy.identifier.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
title	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.title Short description Name for this study Definition A short, descriptive user-friendly label for the study. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Brief Title BRIDG5.1: No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
protocol	Σ	0..*	Reference(PlanDefinition)	There are no (further) constraints on this element Element id ResearchStudy.protocol Short description Steps followed in executing study Definition The set of steps expected to be performed as part of the execution of the study. Data type Reference(PlanDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Interventions; Arm/Intervention Cross-Reference BRIDG5.1: StudyProtocolDocumentVersionPublicTitle.name rim: .outboundRelationship[typeCode=DEFN].target
partOf	Σ	0..*	Reference(ResearchStudy)	There are no (further) constraints on this element Element id ResearchStudy.partOf Short description Part of larger study Alternate names container Definition A larger research study of which this particular study is a component or step. Requirements Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc. Data type Reference(ResearchStudy) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: CompanionStudyRelationship rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
status	Σ ?!	1..1	codeBindingFixed Value	Element id ResearchStudy.status Short description active \| administratively-completed \| approved \| closed-to-accrual \| closed-to-accrual-and-intervention \| completed \| disapproved \| in-review \| temporarily-closed-to-accrual \| temporarily-closed-to-accrual-and-intervention \| withdrawn Definition The current state of the study. Comments The item does not exist in NFDI4Health' MDS. Fixed to 'active' for all studies. Data type code Binding Codes that convey the current status of the research study. ResearchStudyStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed value active Mappings w5: FiveWs.status BRIDG5.1: StudyOverallStatus.code rim: .status
primaryPurposeType	Σ	0..1	CodeableConceptBinding	Element id ResearchStudy.primaryPurposeType Short description treatment \| prevention \| diagnostic \| supportive-care \| screening \| health-services-research \| basic-science \| device-feasibility Definition The type of study based upon the intent of the study's activities. A classification of the intent of the study. Data type CodeableConcept Binding Codes for the main intent of the study. ResearchStudyPrimaryPurposeType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyProtocolVersion.primaryPurposeTypeCode NFDI4Health: Design.primaryPurpose
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.primaryPurposeType.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.primaryPurposeType.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	CodingBinding	Element id ResearchStudy.primaryPurposeType.coding Short description Primary purpose of the [RESOURCE] Definition Specification of the main purpose of the [RESOURCE]. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Additional Information: The field is defined foremost for interventional studies. For non-interventional studies, this field may not be applicable as diverse purposes may be pursued without being able to specify a primary one. In this case, the option 'Not applicable' can be selected. \| Short Input Help: Foremost for interventional studies, please specify the primary purpose why the [RESOURCE] was conducted. For non-interventional studies, this field may be 'Not applicable' as multiple purposes may be defined as primary ones. Data type Coding Binding Value set defining codes to specify the primary purpose of a (sub-)study in a ResearchStudy resource. NFDI4Health_VS_MDS_Study_Primary_Purpose_HL7_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.primaryPurposeType.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
phase	Σ	0..1	CodeableConcept	Element id ResearchStudy.phase Short description n-a \| early-phase-1 \| phase-1 \| phase-1-phase-2 \| phase-2 \| phase-2-phase-3 \| phase-3 \| phase-4 Definition The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. Data type CodeableConcept Binding Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. ResearchStudyPhase (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Phase BRIDG5.1: StudyProtocolVersion.phaseCode NFDI4Health: Design.interventional.phase
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.phase.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.phase.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	CodingBinding	Element id ResearchStudy.phase.coding Short description Numerical phase Definition If applicable, numerical phase of the [RESOURCE]. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Short input help: Select one value from the list. Data type Coding Binding Value set defining codes to specify the phase of a (sub-)study in a ResearchStudy resource. NFDI4Health_VS_MDS_Study_Phase_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.phase.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
category	Σ	1..1	CodeableConceptBinding	Element id ResearchStudy.category Short description Is the study design non-interventional or interventional? Definition Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. Data type CodeableConcept Binding Value set defining codes for primary designs of (sub-)studies in a ResearchStudy resource. NFDI4Health_VS_MDS_Study_Primary_Design_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention BRIDG5.1: InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode NFDI4Health: Design.primaryDesign
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.category.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	1..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.category.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
studyType	I	1..1	Extension(Complex)	Element id ResearchStudy.category.extension:studyType Short description Information on specific study design Alternate names extensions, user content Definition Group of items providing information about the study design. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-type Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A NFDI4Health: Design.studyType
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.category.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.category.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
focus	Σ	0..*	CodeableConcept	Element id ResearchStudy.focus Short description Primary focus of the [RESOURCE] Definition Group of items providing information about the focus of the [RESOURCE] (e.g. medication, food, therapy, device, etc.). Data type CodeableConcept Binding Codes for medications, devices and other interventions. (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Focus of Study w5: FiveWs.what[x] BRIDG5.1: InterventionalStudyProtocol.interventionTypeCode NFDI4Health: Design.focus
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.focus.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.focus.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	1..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
codeableConcept	I	1..1	Extension(Complex)	Element id ResearchStudy.focus.coding.extension:codeableConcept Short description NFDI4Health Codeable Concept Alternate names extensions, user content Definition NFDI4Health Representation of Codeable Concept. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-codeableconcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A NFDI4Health: Design.focus.code NFDI4Health: Design.focus.classification
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	0..1	code	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id ResearchStudy.focus.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	1..1	string	Element id ResearchStudy.focus.text Short description Focus area Definition Focus area of the [RESOURCE] (e.g. medication, food, therapy, device, etc.). Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Additional Information: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD, etc.) is preferred. However, also self-assigned terms are allowed. \| Short input help: Preferably, use terms from SNOMED CT (https://browser.ihtsdotools.org). Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText NFDI4Health: Design.focus.label
condition	Σ	0..*	CodeableConcept	Element id ResearchStudy.condition Short description Primary health conditions or diseases considered in the [RESOURCE] Definition Group of items providing information about primary health conditions or diseases considered in the [RESOURCE]. Data type CodeableConcept Binding Identification of the condition or diagnosis. Condition/Problem/DiagnosisCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Conditions w5: FiveWs.what[x] BRIDG5.1: StudyCondition.code NFDI4Health: Design.conditions
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.condition.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.condition.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	1..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
codeableConcept	I	1..1	Extension(Complex)	Element id ResearchStudy.condition.coding.extension:codeableConcept Short description NFDI4Health Codeable Concept Alternate names extensions, user content Definition NFDI4Health Representation of Codeable Concept. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-codeableconcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A NFDI4Health: Design.conditions.code NFDI4Health: Design.conditions.classification
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	0..1	code	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	1..1	string	Element id ResearchStudy.condition.text Short description Health condition or disease Definition The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Preferably, use terms from terminologies such as SNOMED CT. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of a health condition SARS-CoV-2 Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText NFDI4Health: Design.conditions.label
contact	Σ	0..*	ContactDetail	There are no (further) constraints on this element Element id ResearchStudy.contact Short description Contact details for the study Definition Contact details to assist a user in learning more about or engaging with the study. Data type ContactDetail Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators BRIDG5.1: PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
relatedArtifact		0..1	NFDI4Health_PR_MDS_Related_Artifact_Resource	Element id ResearchStudy.relatedArtifact Short description Related publications, datasets, study documents, web pages, etc. Definition Group of items providing information about identifiers (IDs) of the resources related to the given resource, e.g. DOIs of publications, datasets, study documents or links to web pages. Comments Short input help: If existing, you can specify identifier(s) of any related resources, e.g. DOIs of publications, datasets, study documents, links to web pages, etc. Data type NFDI4Health_PR_MDS_Related_Artifact_Resource Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Citations, Links, Available Study Data/Documents BRIDG5.1: StudyProtocolDocument, StudyProtocolDocumentVersion rim: n/a NFDI4Health: Resource.ids NFDI4Health: Resource.idsNfdi4health NFDI4Health: Resource.webpage
keyword	Σ	0..*	CodeableConcept	Element id ResearchStudy.keyword Short description Keywords Definition Group of items providing information about keywords describing the [RESOURCE]. Comments Additional information: The findability of the [RESOURCE] can be significantly increased if proper keywords are stated. Data type CodeableConcept Binding Words associated with the study that may be useful in discovery. (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Keywords BRIDG5.1: DocumentVersion.keywordCode; DocumentVersion.keywordText NFDI4Health: Resource.keywords
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.keyword.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	0..1	code	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.code.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references) Data type string
extension	I	0..*	Extension	Element id ResearchStudy.keyword.coding.code.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
code	I	0..1	Extension(uri)	Element id ResearchStudy.keyword.coding.code.extension:code Short description Code Alternate names extensions, user content Definition Codein the terminology/classification used. Comments Short input help: If known, you can provide the code from the terminology/classification used. Data type Extension(uri) Extension URL https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Examples Example of an URI for a SNOMED CT concept. http://snomed.info/id/840533007 Mappings rim: n/a rim: N/A NFDI4Health: Resource.keywords.code
value		0..1	System.String	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.code.value Short description Primitive value for code Definition Primitive value for code Data type System.String
display	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	1..1	string	Element id ResearchStudy.keyword.text Short description label Definition Keyword(s) describing the [RESOURCE]. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Additional information: The use of terms from established classifications/vocabularies (e.g. SNOMED CT, MeSH, UMLS) is preferred. However, also self-assigned keywords are allowed. \| Short input help: Preferably, use terms from SNOMED CT or MESH. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Keyword label SARS-CoV-2 Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText NFDI4Health: Resource.keywords.label
location	Σ	0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.location Short description Geographic region(s) for study Definition Indicates a country, state or other region where the study is taking place. Data type CodeableConcept Binding Countries and regions within which this artifact is targeted for use. Jurisdiction ValueSet (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyProtocolVersion.participatingLocationCode
description		0..1	markdown	There are no (further) constraints on this element Element id ResearchStudy.description Short description What this is study doing Definition A full description of how the study is being conducted. Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Detailed Description BRIDG5.1: StudyProtocolDocumentVersion.publicDescription
enrollment	Σ	0..*	Reference(Group)	There are no (further) constraints on this element Element id ResearchStudy.enrollment Short description Inclusion & exclusion criteria Alternate names patient Definition Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes". Comments The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource. Data type Reference(Group) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria) w5: FiveWs.subject[x] BRIDG5.1: InterventionalStudyProtocol.interventionGroupQuantity rim: .participation[typeCode=SBJ].role w5: FiveWs.subject
period	Σ	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.period Short description When the study began and ended Alternate names timing Definition Identifies the start date and the expected (or actual, depending on status) end date for the study. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Start Date (start); Study Completion Date (end) w5: FiveWs.done[x] BRIDG5.1: ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration rim: .effectiveTime
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.period.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.period.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
start	Σ I	0..1	dateTime	Element id ResearchStudy.period.start Short description Start date Definition In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date. Comments Additional information: Preferred date format: DD.MM.YYYY. \| Short input help: In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: DR.1 rim: ./low NFDI4Health: Design.administrativeInformation.startDate
end	Σ I	0..1	dateTime	Element id ResearchStudy.period.end Short description End date Definition In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date. In case of a [RESOURCE] with patients or other participants, it is the date when the last participant is examined or receives an intervention, or the date of the last participant’s last visit. Comments Additional information: Preferred date format: DD.MM.YYYY. \| Short input help: In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date. Meaning when missing If the end of the period is missing, it means that the period is ongoing Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: DR.2 rim: ./high NFDI4Health: Design.administrativeInformation.endDate
sponsor	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id ResearchStudy.sponsor Short description Organization that initiates and is legally responsible for the study Definition An organization that initiates the investigation and is legally responsible for the study. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Sponsor w5: FiveWs.actor BRIDG5.1: RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode rim: .participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
principalInvestigator	Σ	0..1	Reference(Practitioner \| PractitionerRole)	There are no (further) constraints on this element Element id ResearchStudy.principalInvestigator Short description Researcher who oversees multiple aspects of the study Definition A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation. Data type Reference(Practitioner \| PractitionerRole) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Principal Investigator w5: FiveWs.actor BRIDG5.1: StudyInvestigator
site	Σ	0..1	Reference(NFDI4Health_PR_MDS_Centers)	Element id ResearchStudy.site Short description Facility where study activities are conducted Definition A facility in which study activities are conducted. Data type Reference(NFDI4Health_PR_MDS_Centers) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Facility w5: FiveWs.where[x] BRIDG5.1: PlannedStudySite; StudySite
reasonStopped	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped Short description accrual-goal-met \| closed-due-to-toxicity \| closed-due-to-lack-of-study-progress \| temporarily-closed-per-study-design Definition A description and/or code explaining the premature termination of the study. Data type CodeableConcept Binding Codes for why the study ended prematurely. ResearchStudyReasonStopped (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Why Study Stopped w5: FiveWs.why[x] BRIDG5.1: StudyOverallStatus.studyStoppedReasonCode
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..1	CodingBinding	Element id ResearchStudy.reasonStopped.coding Short description Stopping stage Definition Specification of the stage at which the [RESOURCE] was prematurely stopped. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.administrativeInformation.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); otherwise 0..0 / Short Input Help: Select one value from the list. / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Study_Status_Halted_Stage_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding NFDI4Health: Design.administrativeInformation.stageStopped
text	Σ	0..1	string	Element id ResearchStudy.reasonStopped.text Short description Stopping reason Definition Specification of the reasons why the [RESOURCE] was prematurely stopped, for example due to toxicity, closed due to lack of study progress, temporarily closed per study design. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.administrativeInformation.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); otherwise 0..0 / Short Input Help: You can provide reasons such as closed due to toxicity, closed due to lack of [RESOURCE] progress, temporarily-closed per [RESOURCE] design, etc. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText NFDI4Health: Design.administrativeInformation.reasonStopped
note		0..1	Annotation	There are no (further) constraints on this element Element id ResearchStudy.note Short description Comments made about the study Definition Comments made about the study by the performer, subject or other participants. Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: No BRIDG mapping rim: .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.note.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.note.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
author[x]	Σ	0..1		There are no (further) constraints on this element Element id ResearchStudy.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation. Comments Organization is used when there's no need for specific attribution as to who made the comment. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Act.participant[typeCode=AUT].role
authorString			string	There are no (further) constraints on this element Data type string
authorReference			Reference(Practitioner \| Patient \| RelatedPerson \| Organization)	There are no (further) constraints on this element Data type Reference(Practitioner \| Patient \| RelatedPerson \| Organization)
time	Σ	0..1	dateTime	There are no (further) constraints on this element Element id ResearchStudy.note.time Short description When the annotation was made Definition Indicates when this particular annotation was made. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Act.effectiveTime
text	Σ	1..1	markdown	Element id ResearchStudy.note.text Short description Additional information about the [RESOURCE] Definition Any additional information about specific aspects of the [RESOURCE] that could not be captured by other fields.. Comments Short input help: You can provide here specific aspects of the [RESOURCE] that could not be captured by other fields. Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Act.text NFDI4Health: Design.comment
arm		0..*	BackboneElement	There are no (further) constraints on this element Element id ResearchStudy.arm Short description Defined path through the study for a subject Definition Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arms BRIDG5.1: Arm
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.arm.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.arm.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
name		1..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.name Short description Label for study arm Definition Unique, human-readable label for this arm of the study. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Label BRIDG5.1: Arm.name
type		0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.arm.type Short description Categorization of study arm Definition Categorization of study arm, e.g. experimental, active comparator, placebo comparater. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Type BRIDG5.1: Arm.typeCode
description		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.description Short description Short explanation of study path Definition A succinct description of the path through the study that would be followed by a subject adhering to this arm. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Description BRIDG5.1: Arm.description
objective		0..*	BackboneElement	There are no (further) constraints on this element Element id ResearchStudy.objective Short description A goal for the study Definition A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyObjective
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.objective.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.objective.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.objective.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
name		1..1	string	Element id ResearchStudy.objective.name Short description Research questions/hypotheses Definition Statement of the research questions and/or hypotheses underlying the [RESOURCE]. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: No BRIDG mapping (BRIDG has a description, but not a name) NFDI4Health: Design.hypotheses
type		0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.objective.type Short description primary \| secondary \| exploratory Definition The kind of study objective. Data type CodeableConcept Binding Codes for the kind of study objective. ResearchStudyObjectiveType (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyObjective.typeCode

{
    "resourceType": "StructureDefinition",
    "id": "nfdi4health-pr-mds-study",
    "url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
    "version": "0.9",
    "name": "NFDI4Health_PR_MDS_Study",
    "title": "NFDI4Health PR MDS Study",
    "status": "draft",
    "publisher": "NFDI4Health",
    "contact":  [
        {
            "telecom":  [
                {
                    "system": "url",
                    "value": "https://www.nfdi4health.de"
                }
            ]
        }
    ],
    "description": "Group of items applicable only to studies, substudies.",
    "fhirVersion": "4.0.1",
    "mapping":  [
        {
            "identity": "BRIDG5.1",
            "uri": "https://bridgmodel.nci.nih.gov",
            "name": "BRIDG 5.1 Mapping"
        },
        {
            "identity": "v2",
            "uri": "http://hl7.org/v2",
            "name": "HL7 v2 Mapping"
        },
        {
            "identity": "rim",
            "uri": "http://hl7.org/v3",
            "name": "RIM Mapping"
        },
        {
            "identity": "clinicaltrials-gov",
            "uri": "http://clinicaltrials.gov",
            "name": "ClinicalTrials.gov Mapping"
        },
        {
            "identity": "w5",
            "uri": "http://hl7.org/fhir/fivews",
            "name": "FiveWs Pattern Mapping"
        },
        {
            "identity": "NFDI4Health",
            "name": "NFDI4Health to FHIR Mapping"
        }
    ],
    "kind": "resource",
    "abstract": false,
    "type": "ResearchStudy",
    "baseDefinition": "http://hl7.org/fhir/StructureDefinition/ResearchStudy",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "ResearchStudy",
                "path": "ResearchStudy",
                "constraint":  [
                    {
                        "key": "category-interventional-a",
                        "severity": "error",
                        "human": "Cardinality: 1..*, if Design.primaryDesign == 'C98388'",
                        "expression": "category.coding.where(code = 'C98388').exists() implies category.extension.extension.where(url='interventional').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "category-interventional-b",
                        "severity": "error",
                        "human": "Cardinality: 0..0, if Design.primaryDesign != 'C98388'",
                        "expression": "category.coding.where(code = 'C98388').exists().not() implies category.extension.extension.where(url='interventional').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "category-nonInterventional-a",
                        "severity": "error",
                        "human": "Cardinality: 1..*, if Design.primaryDesign == 'C142615''",
                        "expression": "category.coding.where(code = 'C142615').exists() implies category.extension.extension.where(url='nonInterventional').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "category-nonInterventional-b",
                        "severity": "error",
                        "human": "Cardinality: 0..0, if Design.primaryDesign != 'C142615'",
                        "expression": "category.coding.where(code = 'C142615').exists().not() implies category.extension.extension.where(url='nonInterventional').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "study-mortalityData-a",
                        "severity": "error",
                        "human": "Cardinality: 0..1, if Design.studyType.nonInterventional == ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311'))",
                        "expression": "category.extension.extension.where(url='nonInterventional').valueCoding.where(code = 'C15273' or code = 'C15208' or code =  '004' or code =  'D015331' or code =  '005' or code =  'C53311').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "study-mortalityData-b",
                        "severity": "error",
                        "human": "Cardinality: 0..0, if Design.studyType.nonInterventional != ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311'))",
                        "expression": "category.extension.extension.where(url='nonInterventional').valueCoding.where(code = 'C15273' or code = 'C15208' or code = '004' or 'D015331' or code = '005' or code = 'C53311').exists().not() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "study-statusWhenIntervention-a",
                        "severity": "error",
                        "human": "Cardinality: 0..1, if Design.primaryDesign == 'C98388'",
                        "expression": "category.coding.where(code = 'C98388').exists() implies extension.extension.where(url='statusWhenIntervention').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "study-statusWhenIntervention-b",
                        "severity": "error",
                        "human": "Cardinality: 0..1, if Design.administrativeInformation.status == ('01' OR '02' OR '03' OR '04' OR '05')",
                        "expression": "extension.extension.where(url='status').valueCoding.where(code = '01' or code = '02' or code =  '03' or code = '04' or code = '05').exists() implies extension.extension.where(url='statusWhenIntervention').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "study-statusWhenIntervention-c",
                        "severity": "error",
                        "human": "Cardinality: 0..0, if Design.primaryDesign != 'C98388'",
                        "expression": "category.coding.where(code = 'C98388').exists().not() implies extension.extension.where(url='statusWhenIntervention').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "study-statusWhenIntervention-d",
                        "severity": "error",
                        "human": "Cardinality: 0..0, if Design.administrativeInformation.status != ('01' OR '02' OR '03' OR '04' OR '05')",
                        "expression": "extension.extension.where(url='status').valueCoding.where(code = '01' or code = '02' or code =  '03' or code = '04' or code = '05').exists().not() implies extension.extension.where(url='statusWhenIntervention').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "study-recruitmentStatusRegister-a",
                        "severity": "error",
                        "human": "Cardinality: 0..1, if Resource.provenance.dataSource != '06'",
                        "expression": "Composition.extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-provenance-data-source').valueCoding.where(code='06').exists().not() implies extension.extension.where(url='recruitmentStatusRegister').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "study-recruitmentStatusRegister-b",
                        "severity": "error",
                        "human": "Cardinality: 0..0, if Resource.provenance.dataSource == '06'",
                        "expression": "Composition.extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-provenance-data-source').valueCoding.where(code='06').exists() implies extension.extension.where(url='recruitmentStatusRegister').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "probabilityMethod-a",
                        "severity": "error",
                        "human": "0..1, if Design.sampling.method == '034'",
                        "expression": "extension.extension.where(url='method').valueCoding.where(code = '034').exists() implies extension.extension.where(url='probabilityMethod').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "probabilityMethod-b",
                        "severity": "error",
                        "human": "0..0, if Design.sampling.method != '034'",
                        "expression": "extension.extension.where(url='method').valueCoding.where(code = '034').exists().not() implies extension.extension.where(url='probabilityMethod').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "nonProbabilityMethod-a",
                        "severity": "error",
                        "human": "0..1, if Design.sampling.method == 'C127781'",
                        "expression": "extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists() implies extension.extension.where(url='nonProbabilityMethod').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "nonProbabilityMethod-b",
                        "severity": "error",
                        "human": "0..0, if Design.sampling.method != 'C127781'",
                        "expression": "extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists().not() implies extension.extension.where(url='nonProbabilityMethod').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "biosamples-a",
                        "severity": "error",
                        "human": "0..*, if Design.dataSource.general == 'C70699'",
                        "expression": "extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists() implies extension.extension.where(url='biosamples').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "biosamples-b",
                        "severity": "error",
                        "human": "0..0, if Design.dataSource.general != 'C70699'",
                        "expression": "extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists().not() implies extension.extension.where(url='biosamples').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "imaging-a",
                        "severity": "error",
                        "human": "0..*, if Design.dataSource.general == '031'",
                        "expression": "extension.extension.where(url='general').valueCoding.where(code = '031').exists() implies extension.extension.where(url='imaging').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "imaging-b",
                        "severity": "error",
                        "human": "0..0, if Design.dataSource.general != '031'",
                        "expression": "extension.extension.where(url='general').valueCoding.where(code = '031').exists().not() implies extension.extension.where(url='imaging').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "omics-a",
                        "severity": "error",
                        "human": "0..*, if Design.dataSource.general == '033'",
                        "expression": "extension.extension.where(url='general').valueCoding.where(code = '033').exists() implies extension.extension.where(url='omics').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "omics-b",
                        "severity": "error",
                        "human": "0..0, if Design.dataSource.general != '033'",
                        "expression": "extension.extension.where(url='general').valueCoding.where(code = '033').exists().not() implies extension.extension.where(url='omics').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "supportingInformation-a",
                        "severity": "error",
                        "human": "Cardinality: 0..*, if Design.dataSharingPlan.generally == '373066001'",
                        "expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='supportingInformation').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "supportingInformation-b",
                        "severity": "error",
                        "human": "Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001'",
                        "expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='supportingInformation').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "timeFrame-a",
                        "severity": "error",
                        "human": "Cardinality: 0..*, if Design.dataSharingPlan.generally == '373066001'",
                        "expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='timeFrame').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "timeFrame-b",
                        "severity": "error",
                        "human": "Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001'",
                        "expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='timeFrame').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "accessCriteria-a",
                        "severity": "error",
                        "human": "Cardinality: 0..*, if Design.dataSharingPlan.generally == '373066001'",
                        "expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='accessCriteria').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "accessCriteria-b",
                        "severity": "error",
                        "human": "Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001'",
                        "expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='accessCriteria').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "masking-roles-a",
                        "severity": "error",
                        "human": "Cardinality: 0..*, if Design.interventional.masking.general == true",
                        "expression": "extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='roles').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "masking-roles-b",
                        "severity": "error",
                        "human": "Cardinality: 0..*, if Design.interventional.masking.general == false",
                        "expression": "extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='roles').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "masking-description-a",
                        "severity": "error",
                        "human": "Cardinality: 0..*, if Design.interventional.masking.general == true",
                        "expression": "extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='description').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "masking-description-b",
                        "severity": "error",
                        "human": "Cardinality: 0..*, if Design.interventional.masking.general == false",
                        "expression": "extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='description').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "interventional-a",
                        "severity": "error",
                        "human": "Cardinality: 0..1, Design.primaryDesign == 'Interventional'",
                        "expression": "category.coding.where(code = 'C98388').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "interventional-a",
                        "severity": "error",
                        "human": "Cardinality: 0..1, Design.primaryDesign == 'Interventional'",
                        "expression": "category.coding.where(code = 'C98388').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "nonInterventional-a",
                        "severity": "error",
                        "human": "Cardinality: 0..1, Design.primaryDesign == 'Non-interventional'",
                        "expression": "category.coding.where(code = 'C142615').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "nonInterventional-b",
                        "severity": "error",
                        "human": "Cardinality: 0..0, Design.primaryDesign != 'Non-interventional'",
                        "expression": "category.coding.where(code = 'C142615').exists().not() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "study-stageStopped-a",
                        "severity": "error",
                        "human": "Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07')",
                        "expression": "extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.coding.exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "study-stageStopped-b",
                        "severity": "error",
                        "human": "Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07')",
                        "expression": "extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.coding.exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "study-reasonStopped-a",
                        "severity": "error",
                        "human": "Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07')",
                        "expression": "extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.text.exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "study-reasonStopped-b",
                        "severity": "error",
                        "human": "Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07')",
                        "expression": "extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.text.exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "recordLinkage-a",
                        "severity": "error",
                        "human": "Cardinality: 1..1, if Design.dataSharingPlan.recordLinkage == 'Yes'",
                        "expression": "extension.extension.where(url='recordLinkage').where(value=true).exists()  implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "recordLinkage-b",
                        "severity": "error",
                        "human": "Cardinality: 0..0, if Design.dataSharingPlan.recordLinkage == 'No'",
                        "expression": "extension.extension.where(url='recordLinkage').where(value=false).exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "legalBasisDetails-a",
                        "severity": "error",
                        "human": "Cardinality: 1..1, if RecordLinkage.legalBasis == 'True'",
                        "expression": "extension.extension.where(url='legalBasis').where(value=true).exists() implies extension.extension.where(url='legalBasisDetails').exists()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    },
                    {
                        "key": "legalBasisDetails-b",
                        "severity": "error",
                        "human": "Cardinality: 0..0, if RecordLinkage.legalBasis == 'False'",
                        "expression": "extension.extension.where(url='legalBasis').where(value=false).exists() implies extension.extension.where(url='legalBasisDetails').exists().not()",
                        "source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design"
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension",
                "path": "ResearchStudy.extension",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "url"
                        }
                    ],
                    "ordered": false,
                    "rules": "open"
                },
                "min": 5
            },
            {
                "id": "ResearchStudy.extension:descriptions",
                "path": "ResearchStudy.extension",
                "sliceName": "descriptions",
                "min": 1,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-descriptions"
                        ]
                    }
                ],
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Resource.descriptions"
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:mortalityData",
                "path": "ResearchStudy.extension",
                "sliceName": "mortalityData",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:administrativeInformation",
                "path": "ResearchStudy.extension",
                "sliceName": "administrativeInformation",
                "min": 1,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-admin-info"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:subject",
                "path": "ResearchStudy.extension",
                "sliceName": "subject",
                "min": 1,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-subject"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:dataSource",
                "path": "ResearchStudy.extension",
                "sliceName": "dataSource",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-source"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:recruitment",
                "path": "ResearchStudy.extension",
                "sliceName": "recruitment",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-recruitment-backport-r5"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:comparisonGroup",
                "path": "ResearchStudy.extension",
                "sliceName": "comparisonGroup",
                "min": 0,
                "max": "*",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-comparison-group-backport-r5"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:outcomes",
                "path": "ResearchStudy.extension",
                "sliceName": "outcomes",
                "min": 0,
                "max": "*",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:assessments",
                "path": "ResearchStudy.extension",
                "sliceName": "assessments",
                "min": 0,
                "max": "*",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-assessments"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:dataSharingPlan",
                "path": "ResearchStudy.extension",
                "sliceName": "dataSharingPlan",
                "min": 1,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-sharing-plan"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:nonInterventional",
                "path": "ResearchStudy.extension",
                "sliceName": "nonInterventional",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:interventional",
                "path": "ResearchStudy.extension",
                "sliceName": "interventional",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:groupsOfDiseases",
                "path": "ResearchStudy.extension",
                "sliceName": "groupsOfDiseases",
                "min": 1,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-groups-of-diseases"
                        ]
                    }
                ],
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.groupsOfDiseases"
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:sampling",
                "path": "ResearchStudy.extension",
                "sliceName": "sampling",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-sampling"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension:recordLinkage",
                "path": "ResearchStudy.extension",
                "sliceName": "recordLinkage",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.identifier",
                "path": "ResearchStudy.identifier",
                "short": "Alternative identifiers",
                "definition": "Group of items providing information about identifiers (IDs) assigned to the given [RESOURCE] by another registering systems, e.g. a registry of clinical trials or a data repository.",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Resource.idsAlternative"
                    }
                ]
            },
            {
                "id": "ResearchStudy.identifier.type",
                "path": "ResearchStudy.identifier.type",
                "short": "Type of the registry",
                "definition": "Type/name of the system where the given [RESOURCE] is already registered.",
                "min": 1,
                "binding": {
                    "strength": "required",
                    "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-id-type-nci-local",
                    "description": "Value set defining codes to specify the type of a resource identifier."
                },
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Resource.idsAlternative.scheme"
                    }
                ]
            },
            {
                "id": "ResearchStudy.identifier.value",
                "path": "ResearchStudy.identifier.value",
                "definition": "Identifier",
                "min": 1,
                "example":  [
                    {
                        "label": "Identifier (ID) assigned to the given [RESOURCE] by another registering system, e.g. by a registry of clinical trials or a data repository.",
                        "valueString": "ISRCTN91495258"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "esource.idsAlternative.identifier"
                    }
                ]
            },
            {
                "id": "ResearchStudy.status",
                "path": "ResearchStudy.status",
                "comment": "The item does not exist in NFDI4Health' MDS. Fixed to 'active' for all studies.",
                "fixedCode": "active"
            },
            {
                "id": "ResearchStudy.primaryPurposeType",
                "path": "ResearchStudy.primaryPurposeType",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.primaryPurpose"
                    }
                ]
            },
            {
                "id": "ResearchStudy.primaryPurposeType.coding",
                "path": "ResearchStudy.primaryPurposeType.coding",
                "short": "Primary purpose of the [RESOURCE]",
                "definition": "Specification of the main purpose of the [RESOURCE].",
                "comment": "Additional Information: The field is defined foremost for interventional studies. For non-interventional studies, this field may not be applicable as diverse purposes may be pursued without being able to specify a primary one. In this case, the option 'Not applicable' can be selected. | Short Input Help: Foremost for interventional studies, please specify the primary purpose why the [RESOURCE] was conducted. For non-interventional studies, this field may be 'Not applicable' as multiple purposes may be defined as primary ones.",
                "binding": {
                    "strength": "required",
                    "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-primary-purpose-hl7-nci",
                    "description": "Value set defining codes to specify the primary purpose of a (sub-)study in a ResearchStudy resource."
                }
            },
            {
                "id": "ResearchStudy.phase",
                "path": "ResearchStudy.phase",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.interventional.phase"
                    }
                ]
            },
            {
                "id": "ResearchStudy.phase.coding",
                "path": "ResearchStudy.phase.coding",
                "short": "Numerical phase",
                "definition": "If applicable, numerical phase of the [RESOURCE].",
                "comment": "Short input help: Select one value from the list.",
                "binding": {
                    "strength": "required",
                    "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-phase-nci",
                    "description": "Value set defining codes to specify the phase of a (sub-)study in a ResearchStudy resource."
                }
            },
            {
                "id": "ResearchStudy.category",
                "path": "ResearchStudy.category",
                "short": "Is the study design non-interventional or interventional?",
                "min": 1,
                "max": "1",
                "binding": {
                    "strength": "required",
                    "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-primary-design-nci",
                    "description": "Value set defining codes for primary designs of (sub-)studies in a ResearchStudy resource."
                },
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.primaryDesign"
                    }
                ]
            },
            {
                "id": "ResearchStudy.category.extension",
                "path": "ResearchStudy.category.extension",
                "min": 1
            },
            {
                "id": "ResearchStudy.category.extension:studyType",
                "path": "ResearchStudy.category.extension",
                "sliceName": "studyType",
                "min": 1,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-type"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.focus",
                "path": "ResearchStudy.focus",
                "short": "Primary focus of the [RESOURCE]",
                "definition": "Group of items providing information about the focus of the [RESOURCE] (e.g. medication, food, therapy, device, etc.).",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.focus"
                    }
                ]
            },
            {
                "id": "ResearchStudy.focus.coding.extension",
                "path": "ResearchStudy.focus.coding.extension",
                "min": 1
            },
            {
                "id": "ResearchStudy.focus.coding.extension:codeableConcept",
                "path": "ResearchStudy.focus.coding.extension",
                "sliceName": "codeableConcept",
                "min": 1,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-codeableconcept"
                        ]
                    }
                ],
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.focus.code"
                    },
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.focus.classification"
                    }
                ]
            },
            {
                "id": "ResearchStudy.focus.text",
                "path": "ResearchStudy.focus.text",
                "short": "Focus area",
                "definition": "Focus area of the [RESOURCE] (e.g. medication, food, therapy, device, etc.).",
                "comment": "Additional Information: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD, etc.) is preferred. However, also self-assigned terms are allowed. | Short input help: Preferably, use terms from SNOMED CT (https://browser.ihtsdotools.org).",
                "min": 1,
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.focus.label"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition",
                "path": "ResearchStudy.condition",
                "short": "Primary health conditions or diseases considered in the [RESOURCE]",
                "definition": "Group of items providing information about primary health conditions or diseases considered in the [RESOURCE].",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.conditions"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition.coding.extension",
                "path": "ResearchStudy.condition.coding.extension",
                "min": 1
            },
            {
                "id": "ResearchStudy.condition.coding.extension:codeableConcept",
                "path": "ResearchStudy.condition.coding.extension",
                "sliceName": "codeableConcept",
                "min": 1,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-codeableconcept"
                        ]
                    }
                ],
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.conditions.code"
                    },
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.conditions.classification"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition.text",
                "path": "ResearchStudy.condition.text",
                "short": "Health condition or disease",
                "definition": "The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.",
                "comment": "Preferably, use terms from terminologies such as SNOMED CT.",
                "min": 1,
                "example":  [
                    {
                        "label": "Example of a health condition",
                        "valueString": "SARS-CoV-2"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.conditions.label"
                    }
                ]
            },
            {
                "id": "ResearchStudy.relatedArtifact",
                "path": "ResearchStudy.relatedArtifact",
                "max": "1",
                "type":  [
                    {
                        "code": "RelatedArtifact",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-related-artifact-resource"
                        ]
                    }
                ],
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Resource.ids"
                    },
                    {
                        "identity": "NFDI4Health",
                        "map": "Resource.idsNfdi4health"
                    },
                    {
                        "identity": "NFDI4Health",
                        "map": "Resource.webpage"
                    }
                ]
            },
            {
                "id": "ResearchStudy.keyword",
                "path": "ResearchStudy.keyword",
                "short": "Keywords",
                "definition": "Group of items providing information about keywords describing the [RESOURCE].",
                "comment": "Additional information: The findability of the [RESOURCE] can be significantly increased if proper keywords are stated.",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Resource.keywords"
                    }
                ]
            },
            {
                "id": "ResearchStudy.keyword.coding.code.extension",
                "path": "ResearchStudy.keyword.coding.code.extension",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "url"
                        }
                    ],
                    "ordered": false,
                    "rules": "open"
                }
            },
            {
                "id": "ResearchStudy.keyword.coding.code.extension:code",
                "path": "ResearchStudy.keyword.coding.code.extension",
                "sliceName": "code",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-code"
                        ]
                    }
                ],
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Resource.keywords.code"
                    }
                ]
            },
            {
                "id": "ResearchStudy.keyword.text",
                "path": "ResearchStudy.keyword.text",
                "short": "label",
                "definition": "Keyword(s) describing the [RESOURCE].",
                "comment": "Additional information: The use of terms from established classifications/vocabularies (e.g. SNOMED CT, MeSH, UMLS) is preferred. However, also self-assigned keywords are allowed. | Short input help: Preferably, use terms from SNOMED CT or MESH.",
                "min": 1,
                "example":  [
                    {
                        "label": "Keyword label",
                        "valueString": "SARS-CoV-2"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Resource.keywords.label"
                    }
                ]
            },
            {
                "id": "ResearchStudy.period.start",
                "path": "ResearchStudy.period.start",
                "short": "Start date",
                "definition": "In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date.",
                "comment": "Additional information: Preferred date format: DD.MM.YYYY. | Short input help: In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date.",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.administrativeInformation.startDate"
                    }
                ]
            },
            {
                "id": "ResearchStudy.period.end",
                "path": "ResearchStudy.period.end",
                "short": "End date",
                "definition": "In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date. In case of a [RESOURCE] with patients or other participants, it is the date when the last participant is examined or receives an intervention, or the date of the last participant’s last visit.",
                "comment": "Additional information: Preferred date format: DD.MM.YYYY. | Short input help: In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date.",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.administrativeInformation.endDate"
                    }
                ]
            },
            {
                "id": "ResearchStudy.site",
                "path": "ResearchStudy.site",
                "max": "1",
                "type":  [
                    {
                        "code": "Reference",
                        "targetProfile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-centers"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.reasonStopped.coding",
                "path": "ResearchStudy.reasonStopped.coding",
                "short": "Stopping stage",
                "definition": "Specification of the stage at which the [RESOURCE] was prematurely stopped.",
                "comment": "Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.administrativeInformation.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); otherwise 0..0 / Short Input Help: Select one value from the list. / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3]",
                "max": "1",
                "binding": {
                    "strength": "required",
                    "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-status-halted-stage-local"
                },
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.administrativeInformation.stageStopped"
                    }
                ]
            },
            {
                "id": "ResearchStudy.reasonStopped.text",
                "path": "ResearchStudy.reasonStopped.text",
                "short": "Stopping reason",
                "definition": "Specification of the reasons why the [RESOURCE] was prematurely stopped, for example due to toxicity, closed due to lack of study progress, temporarily closed per study design.",
                "comment": "Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.administrativeInformation.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); otherwise 0..0 / Short Input Help: You can provide reasons such as closed due to toxicity, closed due to lack of [RESOURCE] progress, temporarily-closed per [RESOURCE] design, etc. / Source of the property and/or allowed values: CT.gov [2], DRKS [3]",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.administrativeInformation.reasonStopped"
                    }
                ]
            },
            {
                "id": "ResearchStudy.note",
                "path": "ResearchStudy.note",
                "max": "1"
            },
            {
                "id": "ResearchStudy.note.text",
                "path": "ResearchStudy.note.text",
                "short": "Additional information about the [RESOURCE]",
                "definition": "Any additional information about specific aspects of the [RESOURCE] that could not be captured by other fields..",
                "comment": "Short input help: You can provide here specific aspects of the [RESOURCE] that could not be captured by other fields.",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.comment"
                    }
                ]
            },
            {
                "id": "ResearchStudy.objective.name",
                "path": "ResearchStudy.objective.name",
                "short": "Research questions/hypotheses",
                "definition": "Statement of the research questions and/or hypotheses underlying the [RESOURCE].",
                "min": 1,
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.hypotheses"
                    }
                ]
            }
        ]
    }
}

Examples

Example data for NFDI4Health PR MDS Study used to represent metadata from studies

Example of an interventional study using NFDI4Health PR MDS Study - Sport & Long-COVID-Syndrom (SPOVID)
InstanceOfStudySPOVID

Example of an non-interventional study using NFDI4Health PR MDS Study - Study of Health in Pomerania Trend (SHIP-Trend)
InstanceOfStudySHIP