Logical Models

The following logical models are based on the current metadata schema version 3.3 as presented in our ART-DECOR project.

They do not take into account any mapping to FHIR.

General MDS modules

Core

nfdi4health-lm-mds-core			nfdi4health-lm-mds-core	Element id nfdi4health-lm-mds-core Short description NFDI4Health LM Core Metadataschema Definition NFDI4Health Logical Model Core Metadataschema Data type nfdi4health-lm-mds-core Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.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 nfdi4health-lm-mds-core.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 rim: N/A
Resource		1..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource Short description Resource Definition Group of items providing information about a resource. Resources can be, for example, files or parts of them (e.g. datasets or study documents such as study protocols or questionnaires) or also studies or substudies. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.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 nfdi4health-lm-mds-core.Resource.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.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 rim: N/A
identifier		1..1	string	Element id nfdi4health-lm-mds-core.Resource.identifier Short description ID of the [RESOURCE] Definition Unique identifier of the resource used for identification within the NFDI4Health. Comments Additional information: The identifier is assigned automatically. / Source of the property and/or allowed values: NFDI4Health, DataCite [1] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
classification		1..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.classification Short description Resource classification Definition Group of items providing information about the classification of the resource within the predefined categories. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.classification.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 nfdi4health-lm-mds-core.Resource.classification.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.classification.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 rim: N/A
type		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.classification.type Short description Type of the resource Definition A term describing the resource. Comments Additional information: The selected resource type determines which information will be asked next. / Short Input Help: You can register a study, a study protocol, a questionnaire, etc. Please only add follow up questionnaires if baseline questionnaires have already been registered. / Source of the property and/or allowed values: DataCite [1] Data type Coding Binding NFDI4Health_VS_MDS_Resource_Type_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
typeGeneral		0..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.classification.typeGeneral Short description In what form is the [RESOURCE] available? Definition Specific information about the form in which the [RESOURCE] is available. Comments Cardinality: 1..1, if Resource.classification.type != ('Study' OR 'Substudy' OR 'Dataset' OR 'Registry' OR 'Secondary data source'); otherwise 0..0 / Additional Information: If the [RESOURCE] consists primarily of words for reading and is not covered by another textual resource type in this list, 'Text' should be used instead of 'Other'. / Short Input Help: You can select 'Text' for most of the study documents, e.g. for questionnaires, informed consent forms, case report forms, etc. / Source of the property and/or allowed values: DataCite [1] Data type Coding Binding NFDI4Health_VS_MDS_Resource_Type_General_NCI_MSH_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
titles		1..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.titles Short description Title(s)/name(s) of the [RESOURCE] Definition Group of items providing information about title(s)/name(s) of the [RESOURCE]. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.titles.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 nfdi4health-lm-mds-core.Resource.titles.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.titles.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 rim: N/A
text		1..1	string	Element id nfdi4health-lm-mds-core.Resource.titles.text Short description Title/name Definition Scientific unabbreviated title or name of the [RESOURCE]. Comments Additional information: If no official title/name has been defined yet, a title/name that is suitable for public display should be used. / Short Input Help: Please provide at least one title/name of the [RESOURCE]. If the original title is not in English, please also provide an English translation of the original title. / Source of the property and/or allowed values: NFDI4Health, DataCite [1], 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 rim: n/a
language		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.titles.language Short description Language of the title/name Definition Language in which the title/name is provided. Comments Source of the property and/or allowed values: NFDI4Health, DataCite [1], CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Languages_ISO (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
acronyms		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.acronyms Short description Acronym(s) of the [RESOURCE] Definition Group of items providing information about acronym(s) of the [RESOURCE]. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.acronyms.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 nfdi4health-lm-mds-core.Resource.acronyms.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.acronyms.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 rim: N/A
text		1..1	string	Element id nfdi4health-lm-mds-core.Resource.acronyms.text Short description Acronym Definition If existing, acronym(s) of the [RESOURCE]. Comments Additional Information: The field refers primarily to resources which have an acronym. / Short Input Help: If no acronym exists, you can provide a short title, preferably up to 5 words, e.g. 'NAKO-COVID Questionnaire'. / 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 rim: n/a
language		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.acronyms.language Short description Language of the acronym Definition Language in which the acronym is provided. Comments Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Languages_ISO (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
descriptions		1..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.descriptions Short description Description(s) of the [RESOURCE] Definition Group of items providing information about the description(s) of the [RESOURCE]. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.descriptions.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 nfdi4health-lm-mds-core.Resource.descriptions.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.descriptions.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 rim: N/A
text		1..1	string	Element id nfdi4health-lm-mds-core.Resource.descriptions.text Short description Description Definition Short plain text summary of the [RESOURCE]. Comments Short Input Help: Please provide a description in the original language of the [RESOURCE]. If the original language is not English, please also provide a full English translation of the description. / Source of the property and/or allowed values: NFDI4Health, DataCite [1], 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 rim: n/a
language		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.descriptions.language Short description Language of the description Definition Language in which the description text is provided. Comments Source of the property and/or allowed values: NFDI4Health, DataCite [1], CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Languages_ISO (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
keywords		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.keywords Short description Keyword(s) describing the [RESOURCE] 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. / Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.keywords.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 nfdi4health-lm-mds-core.Resource.keywords.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.keywords.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 rim: N/A
label		1..1	string	Element id nfdi4health-lm-mds-core.Resource.keywords.label Short description Keyword Definition Keyword(s) describing the [RESOURCE]. 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. / Source of the property and/or allowed values: DataCite [1], 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())` Examples Example of a keyword label SARS-CoV-2 Mappings rim: n/a
code		0..1	uri	Element id nfdi4health-lm-mds-core.Resource.keywords.code Short description Code of the keyword Definition If known, the code of the keyword in the classification/vocabulary used. Comments Short Input Help: If known, you can provide the code of the keyword in the classification/vocabulary used. / Source of the property and/or allowed values: DataCite [1], CT.gov [2], DRKS [3] Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of a keyword code http://id.nlm.nih.gov/mesh/D000086402 Mappings rim: n/a
languages		0..*	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.languages Short description Language(s) of the [RESOURCE] Definition Language(s) in which the [RESOURCE] is conducted/provided. Comments Short Input Help: Select all that apply. / Source of the property and/or allowed values: DataCite [1] Data type Coding Binding NFDI4Health_VS_MDS_Languages_ISO (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
webpage		0..1	url	Element id nfdi4health-lm-mds-core.Resource.webpage Short description Web page of the [RESOURCE] Definition If existing, a link to the web page directly relevant to the [RESOURCE]. Comments Additional Information: Other web pages related to the [RESOURCE] can additionally be entered in the section 'Related resources'. / Source of the property and/or allowed values: DataCite [1], CT.gov [2], DRKS [3] Data type url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
nonStudyDetails		0..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails Short description Detailed information about the [RESOURCE] Definition Group of items applicable only to resource types other than a study/substudy, a dataset, a registry, or a secondary data source. Comments Cardinality: 1..1, if Resource.classification.type != ('Study' OR 'Substudy' OR 'Registry' OR 'Secondary data source'); otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.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 nfdi4health-lm-mds-core.Resource.nonStudyDetails.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.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 rim: N/A
version		0..1	string	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.version Short description Version Definition If applicable, the version number of the [RESOURCE]. Comments Source of the property and/or allowed values: DataCite [1] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
format		0..1	string	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.format Short description Format Definition If applicable, the file format of the [RESOURCE] (e.g., XML, PDF, XLSX, etc.). Comments Source of the property and/or allowed values: DataCite [1] 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 format PDF Mappings rim: n/a
useRights		1..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights Short description (Re-)use rights Definition Group of items providing information about the rights to (re-)use the [RESOURCE]. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.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 nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.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 rim: N/A
label		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.label Short description License Definition License defining the rights to (re-)use the [RESOURCE]. Comments Short Input Help: Select one value from the list. If 'Other' is selected, please provide an explanation of the (re-)use terms and conditions in the field 'Additional information about use rights'. / Source of the property and/or allowed values: NFDI4Health, DataCite [1] Data type Coding Binding NFDI4Health_VS_MDS_Use_Rights_Label_SPDX_SNOMED_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
link		0..1	url	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.link Short description URL of the license Definition Link to the selected license. Comments Cardinality: 0..1, if Resource.nonStudyDetails.useRights.label == 'Other'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health, DataCite [1] Data type url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
confirmations		0..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations Short description Licensing confirmations Definition Group of items applicable only if a Creative Commons license is selected. Comments Cardinality: 1..1, if Resource.nonStudyDetails.useRights.label != ('CC0 1.0 (Creative Commons Zero v1.0 Universal') OR 'All rights reserved' OR 'Other' OR 'Not applicable' OR 'Unknown'); otherwise 0..0 / Additional Information: In order to successfully publish the [RESOURCE] under the respective license, all four questions ought to be confirmed. / Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.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 nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.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 rim: N/A
authority		1..1	boolean	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.authority Short description Do you confirm that the authors of the [RESOURCE] have authority to license it? Definition Confirmation that the authors of the [RESOURCE] have authority to license it. Comments Source of the property and/or allowed values: NFDI4Health Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
terms		1..1	boolean	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.terms Short description Do you confirm that the authors of the [RESOURCE] have read and understood the terms of the chosen license? Definition Confirmation that the authors of the [RESOURCE] have read and understood the terms of the chosen license. Comments Source of the property and/or allowed values: NFDI4Health Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
irrevocability		1..1	boolean	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.irrevocability Short description Do you confirm that the authors of the [RESOURCE] understand that Creative Commons (CC) licensing is irrevocable? Definition Confirmation that the authors of the [RESOURCE] understand that Creative Commons (CC) licensing is not revocable. Comments Additional Information: The [RESOURCE] can be licensed using a CC-license only if it is free of the third-party rights. / Source of the property and/or allowed values: NFDI4Health Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
supportByLicensing		1..1	boolean	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.supportByLicensing Short description Do you confirm that the authors of the [RESOURCE] allow NFDI4Health to license the document? Definition Confirmation that NFDI4Health is allowed to license the document, i.e. to mark the [RESOURCE] with the license information. Comments Source of the property and/or allowed values: NFDI4Health Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
description		0..1	string	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.description Short description Additional information about use rights Definition Any additional descriptive information explaining terms and conditions to (re-)use the [RESOURCE]. Comments Additional Information: If 'Other' is selected in the field 'License', the preferred license or terms and conditions for (re-)use should be specified here. / Source of the property and/or allowed values: NFDI4Health, DataCite [1] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
contributors		1..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.contributors Short description Contributor(s) of the [RESOURCE] Definition Group of items providing information about person(s), group(s) of persons or institution(s)/organisation(s) Comments Additional Information: For each [RESOURCE], there may be multiple contributors, but at least one person, group of persons or institution/organisation must be specified. / Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.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 nfdi4health-lm-mds-core.Resource.contributors.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.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 rim: N/A
nameType		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.contributors.nameType Short description Is it a personal or organisational contribution? Definition Indication whether the contribution was made by person(s) or organisation(s)/institution(s)/group(s). Comments Source of the property and/or allowed values: NFDI4Health, DataCite [1] Data type Coding Binding NFDI4Health_VS_MDS_Role_Name_Type_SNOMEDCT (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
organisational		0..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.contributors.organisational Short description Details about the contributing organisation(s)/institution(s)/group(s) Definition Group of items providing information about group(s) of persons, institution(s) or organisation(s) contributing to the [RESOURCE]. Comments Cardinality: 1..1, if Resource.contributors.nameType == 'Organisational'; otherwise 0..0 / Additional Information: Group of items applicable only when providing organisational, institutional or group names. / Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.organisational.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 nfdi4health-lm-mds-core.Resource.contributors.organisational.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.organisational.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 rim: N/A
type		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.contributors.organisational.type Short description Contributor type Definition Contributor type an organisation, institution or group fulfills. For example, this can be a sponsor of the study or a group of authors of the document. Comments Short Input Help: Which contributor type does the organisation, institution or group fulfill? Select one value from the list. / Source of the property and/or allowed values: DataCite [1], CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Organisational_Roles_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
fundingIds		0..*	string	Element id nfdi4health-lm-mds-core.Resource.contributors.organisational.fundingIds Short description Funding identifier(s) Definition Identifier(s) assigned by a funder to the [RESOURCE]. Comments Cardinality: 0.., if Resource.contributors.organisational.type == ('Funder (public)' OR 'Funder (private)'); otherwise 0..0 / Short Input Help: If available, you can enter funding identifiers. / Source of the property and/or allowed values: NFDI4Health, DataCite [1], CT.gov [2] Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
name		1..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.organisational.name Short description Name of the organisation/institution/group Definition Name of the organisation, institution or group. Comments Short Input Help: An organisational name can be used to denote a research group or an institution. / Source of the property and/or allowed values: NFDI4Health, DataCite [1], DataCite [1], 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 rim: n/a
personal		0..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.contributors.personal Short description Details about the contributing person(s) Definition Group of items providing information about person(s) contributing to the [RESOURCE]. Comments Cardinality: 1..1, if Resource.contributors.nameType == 'Personal'; otherwise 0..0 / Additional Information: Group of items applicable only when providing person names. / Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.personal.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 nfdi4health-lm-mds-core.Resource.contributors.personal.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.personal.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 rim: N/A
type		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.contributors.personal.type Short description Contributor type Definition Contributor type a person fulfills. For example, this can be a principal investigator of a study or an author of a document. Comments Short Input Help: Which contributor type does the person fulfill? Select one value from the list. / Source of the property and/or allowed values: DataCite [1], CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Personal_Roles_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
givenName		1..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.personal.givenName Short description Given name Definition Given name of the person. Comments Source of the property and/or allowed values: DataCite [1], 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 rim: n/a
familyName		1..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.personal.familyName Short description Family name(s) Definition Family name(s) of the person. Comments Source of the property and/or allowed values: DataCite [1], 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 rim: n/a
identifiers		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.contributors.personal.identifiers Short description Digital identifier(s) Definition Group of items providing information about digital identifiers of the person. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.personal.identifiers.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 nfdi4health-lm-mds-core.Resource.contributors.personal.identifiers.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.personal.identifiers.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 rim: N/A
identifier		1..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.personal.identifiers.identifier Short description Identifier Definition Digital identifier according to a specific scheme that uniquely identifies the person. Comments Short Input Help: Preferably, provide an ORCID (https://orcid.org/). / Source of the property and/or allowed values: DataCite [1] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of an ORCID 0000-0003-1379-7023 Mappings rim: n/a
scheme		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.contributors.personal.identifiers.scheme Short description Scheme Definition Type of the identifier scheme reported. Comments Source of the property and/or allowed values: DataCite [1] Data type Coding Binding NFDI4Health_VS_MDS_Role_Name_Identifier_Scheme_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of an Identifier System { "coding": [ { "system": "https://www.nfdi4health.de/fhir/metadataschema/CodeSystem/nfdi4health-cs-remaining-concepts", "code": "080", "display": "ORCID" } ], "text": "ORCID" } Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
email		0..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.email Short description Email address Definition Email address of the person, group of persons or institution/organisation. Comments 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 rim: n/a
phone		0..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.phone Short description Phone number Definition Phone number of the person, group of persons or institution/organisation. Comments Short Input Help: Please use the International ITU-T E.164-number structure for geographic areas. / 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())` Examples Example of a Phone Number +49 (0)153 1112233 Mappings rim: n/a
affiliations		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations Short description Organisation(s) associated with the contributor Definition Group of items providing further information about the organisation(s) associated with the contributor. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.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 nfdi4health-lm-mds-core.Resource.contributors.affiliations.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.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 rim: N/A
name		1..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.name Short description Name Definition Name of the organisation associated with the contributor. Comments Short Input Help: If you have already entered the name of the organistion in the field 'Name of the organisation/institution/group', please repeat it here. / Source of the property and/or allowed values: DataCite[1], CT.gov [2], DRKS [3], NFDI4Health Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
address		0..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.address Short description Address Definition Address of the organisation associated with the contributor. Comments Short Input Help: Please preferably use the following address format: Street name and number [comma] post code [comma] city [comma] country. / Source of the property and/or allowed values: CT.gov [2], DRKS [3], NFDI4Health Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of an address of a contributor Gleueler Straße 60, 50931, Cologne, Germany Mappings rim: n/a
webpage		0..1	url	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.webpage Short description Web page Definition Web page of the organisation associated with the contributor. Comments Source of the property and/or allowed values: DRKS [3] Data type url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
identifiers		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.identifiers Short description Digital identifier(s) Definition Group of items providing information about identifiers of the organisation. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.identifiers.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 nfdi4health-lm-mds-core.Resource.contributors.affiliations.identifiers.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.identifiers.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 rim: N/A
identifier		1..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.identifiers.identifier Short description Identifier Definition Digital identifier according to a specific scheme that uniquely identifies the organisation. Comments Short Input Help: Preferably, provide an identifier from ROR (https://ror.org/search). / Source of the property and/or allowed values: DataCite [1] 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 ROR identifier 0259fwx54 Mappings rim: n/a
scheme		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.identifiers.scheme Short description Scheme Definition Type of the identifier scheme reported. Comments Source of the property and/or allowed values: DataCite [1] Data type Coding Binding NFDI4Health_VS_MDS_Role_Affiliation_Identifier_Scheme_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of an Identifier System { "coding": [ { "system": "https://www.nfdi4health.de/fhir/metadataschema/CodeSystem/nfdi4health-cs-remaining-concepts", "code": "081", "display": "ROR" } ], "text": "ROR" } Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
idsAlternative		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.idsAlternative 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. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.idsAlternative.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 nfdi4health-lm-mds-core.Resource.idsAlternative.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.idsAlternative.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 rim: N/A
scheme		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.idsAlternative.scheme Short description Type of the registry Definition Type/name of the system where the given [RESOURCE] is already registered. Comments Source of the property and/or allowed values: NFDI4Health Data type Coding Binding 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())` Examples Example of a registry { "coding": [ { "system": "https://www.nfdi4health.de/fhir/metadataschema/CodeSystem/nfdi4health-cs-remaining-concepts", "code": "098", "display": "DRKS" } ], "text": "DRKS" } Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
identifier		1..1	string	Element id nfdi4health-lm-mds-core.Resource.idsAlternative.identifier Short description Identifier Definition Identifier (ID) assigned to the given [RESOURCE] by another registering system, e.g. by a registry of clinical trials or a data repository. Comments Short Input Help: If the [RESOURCE] is registered in other systems (e.g. a registry of clinical trials or a data repository), you can provide here corresponding identifier(s) such as DRKS00021273, NCT04327505, etc. / Source of the property and/or allowed values: NFDI4Health, DataCite [1] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of an Identifier ISRCTN91495258 Mappings rim: n/a
ids		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.ids Short description Related resources 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 Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.ids.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 nfdi4health-lm-mds-core.Resource.ids.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.ids.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 rim: N/A
identifier		1..1	string	Element id nfdi4health-lm-mds-core.Resource.ids.identifier Short description Identifier of the related resource Definition Identifier (ID) related to, or associated with, the [RESOURCE] being registered. These can be IDs of related publications, datasets, study documents, web pages, etc. Comments Additional Information: a) Publications like journal articles usually have a DOI, e.g. 10.3238/arztebl.2020.0861. b) A link (URL) starting with 'http(s)://' to a web page with any additional information can also be provided. / Short Input Help: If existing, you can specify here identifier(s) of any related resources, e.g. DOIs of publications, datasets, study documents, links to web pages, etc. / Source of the property and/or allowed values: DataCite [1] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of an Identifier 10.4126/FRL01-006431467 Mappings rim: n/a
scheme		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.ids.scheme Short description Type of the identifier Definition Type of the identifier of the related resource. Comments Short Input Help: Select one value from the list. / Source of the property and/or allowed values: DataCite [1] Data type Coding Binding NFDI4Health_VS_MDS_Identifier_Type_Related_Artifact_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of an Identifier System { "text": "DOI" } Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
relationType		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.ids.relationType Short description Relationship between this [RESOURCE] (A) and the related resource (B) Definition Relationship between the [RESOURCE] being registered (A) and the related resource (B). Comments Short Input Help: Select one value from the list. / Source of the property and/or allowed values: DataCite [1] Data type Coding Binding NFDI4Health_VS_MDS_Relation_Type_Ids_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of a relationship between two resources { "coding": [ { "system": "https://www.nfdi4health.de/fhir/metadataschema/CodeSystem/nfdi4health-cs-remaining-concepts", "code": "065", "display": "A is part of B" } ], "text": "A is part of B" } Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
typeGeneral		0..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.ids.typeGeneral Short description Type of the related resource Definition Type of the related resource, e.g. journal article, dataset, text, etc. Comments Short Input Help: Select one value from the list./ Source of the property and/or allowed values: DataCite [1] Data type Coding Binding NFDI4Health_VS_MDS_Resource_Type_General_NCI_MSH_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of a related resource type { "text": "Text" } Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
idsNfdi4health		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.idsNfdi4health Short description Related resources registered on this portal Definition Group of items providing information about related resources (e.g. (sub-)studies, study documents, etc.) registered on this portal. Comments Additional Information: Does the [RESOURCE] have any related resources registered on this portal? / Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.idsNfdi4health.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 nfdi4health-lm-mds-core.Resource.idsNfdi4health.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.idsNfdi4health.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 rim: N/A
identifier		1..1	string	Element id nfdi4health-lm-mds-core.Resource.idsNfdi4health.identifier Short description Identifier of the related resource Definition Identifier (ID) of the related resource assigned on this portal. Comments Source of the property and/or allowed values: NFDI4Health Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of an Identifier assigned by NFDI4Health 39 Mappings rim: n/a
date		0..1	date	Element id nfdi4health-lm-mds-core.Resource.idsNfdi4health.date Short description Date of ID assignment Definition Date when the identifier of the related resource was assigned. Comments Additional Information: Preferred date format: DD.MM.YYYY. / Source of the property and/or allowed values: NFDI4Health Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
relationType		0..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.idsNfdi4health.relationType Short description Relationship between this [RESOURCE] (A) and the related resource (B) Definition Relationship between the [RESOURCE] being registered (A) and the related resource (B). Comments Source of the property and/or allowed values: DataCite [1] Data type Coding Binding NFDI4Health_VS_MDS_Relation_Type_Ids_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
nutritionalData		0..1	boolean	Element id nfdi4health-lm-mds-core.Resource.nutritionalData Short description Collects nutritional data? Definition Indication whether the [RESOURCE] collects nutritional data. Comments Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Resource.provenance.dataSource == 'Manually collected'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
chronicDiseases		0..1	boolean	Element id nfdi4health-lm-mds-core.Resource.chronicDiseases Short description Includes chronic diseases? Definition Indication whether the [RESOURCE] addresses chronic diseases. Comments Cardinality: 1..1, if Resource.provenance.dataSource == 'Manually collected'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.2 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
provenance		1..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.provenance Short description Provenance aspects of data entry Definition Group of items providing information about provenance aspects of the data entry on this portal. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.provenance.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 nfdi4health-lm-mds-core.Resource.provenance.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.provenance.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 rim: N/A
dataSource		1..1	CodingBinding	Element id nfdi4health-lm-mds-core.Resource.provenance.dataSource Short description Source of information about the [RESOURCE] Definition Source of information about the [RESOURCE] and the way it was uploaded/collected. Comments Source of the property and/or allowed values: NFDI4Health Data type Coding Binding NFDI4Health_VS_MDS_Provenance_Data_Source_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
verificationDate		0..1	date	Element id nfdi4health-lm-mds-core.Resource.provenance.verificationDate Short description Last verified on Definition Date on which the responsible party last verified the information about the [RESOURCE], even if no additional or updated information is being submitted. Comments Source of the property and/or allowed values: CT.gov [2] Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
verificationUser		0..1	Coding	Element id nfdi4health-lm-mds-core.Resource.provenance.verificationUser Short description Last verified by Definition User who last verified the information about the [RESOURCE]. Comments Source of the property and/or allowed values: CT.gov [2] Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
firstSubmittedDate		0..1	date	Element id nfdi4health-lm-mds-core.Resource.provenance.firstSubmittedDate Short description First submitted on Definition Date when the [RESOURCE] was first submitted for publication. Comments Source of the property and/or allowed values: CT.gov [2] Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
firstSubmittedUser		0..1	Coding	Element id nfdi4health-lm-mds-core.Resource.provenance.firstSubmittedUser Short description First submitted by Definition User who first submitted the [RESOURCE] for publication. Comments Source of the property and/or allowed values: CT.gov [2] Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
firstPostedDate		0..1	date	Element id nfdi4health-lm-mds-core.Resource.provenance.firstPostedDate Short description First posted/published on Definition Date when the [RESOURCE] was first posted/published. Comments Source of the property and/or allowed values: CT.gov [2] Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
firstPostedUser		0..1	Coding	Element id nfdi4health-lm-mds-core.Resource.provenance.firstPostedUser Short description First posted/published by Definition User who first posted/published the [RESOURCE]. Comments Source of the property and/or allowed values: CT.gov [2] Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
lastUpdateSubmittedDate		0..1	date	Element id nfdi4health-lm-mds-core.Resource.provenance.lastUpdateSubmittedDate Short description Last update submitted on Definition Date when the last update of the [RESOURCE] was submitted for publication. Comments Source of the property and/or allowed values: CT.gov [2] Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
lastUpdateSubmittedUser		0..1	Coding	Element id nfdi4health-lm-mds-core.Resource.provenance.lastUpdateSubmittedUser Short description Last updated submitted by Definition User who submitted the last update of the [RESOURCE]. Comments Source of the property and/or allowed values: CT.gov [2] Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
lastUpdatePostedDate		0..1	date	Element id nfdi4health-lm-mds-core.Resource.provenance.lastUpdatePostedDate Short description Last update posted/published on Definition Date when the last update of the [RESOURCE] was posted/published. Comments Source of the property and/or allowed values: CT.gov [2] Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
lastUpdatePostedUser		0..1	Coding	Element id nfdi4health-lm-mds-core.Resource.provenance.lastUpdatePostedUser Short description Last update posted/published by Definition User who posted/published the last update of the [RESOURCE]. Comments Source of the property and/or allowed values: CT.gov [2] Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
resourceVersion		0..1	string	Element id nfdi4health-lm-mds-core.Resource.provenance.resourceVersion Short description Version number Definition Version number of the [RESOURCE] within this portal. Comments Source of the property and/or allowed values: CT.gov [2] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a

Design

nfdi4health-lm-mds-design-v3-3			nfdi4health-lm-mds-design-v3-3	Element id nfdi4health-lm-mds-design-v3-3 Short description NFDI4Health LM MDS Module Design Definition NFDI4Health Logical Model MDS Module Design V3.3 Data type nfdi4health-lm-mds-design-v3-3 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.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 nfdi4health-lm-mds-design-v3-3.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 rim: N/A
Design		0..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design Short description Characteristics of the [RESOURCE] Definition Group of items providing information about the characteristics of a [RESOURCE]. Comments Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy' OR 'Registry' OR 'Secondary data source'); otherwise 0..0 / Additional Information: Group of items applicable only to studies, substudies, registries, and secondary data sources. / Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.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 nfdi4health-lm-mds-design-v3-3.Design.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.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 rim: N/A
primaryDesign		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.primaryDesign Short description Is it an interventional or non-interventional [RESOURCE]? Definition Non-interventional design refers to a [RESOURCE] that does not aim to alter its outcomes of interest. Interventional design refers to a [RESOURCE] that aims to alter its outcomes of interest. Comments Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0 / Short Input Help: Select between non-interventional and interventional design for the given [RESOURCE]. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type Coding Binding 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 rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
studyType		0..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.studyType Short description Specification of the type of the [RESOURCE] Definition Group of items providing information about the type of the [RESOURCE]. Comments Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0 / Source of the property and/or allowed values: CT.gov [2], DRKS [3], DDI [7], MIABIS [6] Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.studyType.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 nfdi4health-lm-mds-design-v3-3.Design.studyType.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.studyType.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 rim: N/A
interventional		0..*	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.studyType.interventional Short description Interventional [RESOURCE] type Definition The strategy for assigning interventions to participants. Comments Cardinality: 1.., if Design.primaryDesign == 'Interventional'; otherwise 0..0 / Short Input Help: Select all that apply. If 'Other' is selected, please specify the type of the [RESOURCE] in the field 'Additional information about the [RESOURCE]'. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type* Coding Binding NFDI4Health_VS_MDS_Study_Type_Interventional_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
nonInterventional		0..*	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.studyType.nonInterventional Short description Non-interventional [RESOURCE] type Definition The primary strategy for participant identification and follow-up. Comments Cardinality: 1.., if Design.primaryDesign == 'Non-interventional'; otherwise 0..0 / Short Input Help: Select all that apply. If 'Other' is selected, please specify the type of the [RESOURCE] in the field 'Additional information about the [RESOURCE]'./ Source of the property and/or allowed values: CT.gov [2], DRKS [3], DDI [7], MIABIS [6] Data type* Coding Binding NFDI4Health_VS_MDS_Study_Type_Non_Interventional_NCI_MSH_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
conditions		0..*	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.conditions Short description Primary health condition(s) or disease(s) considered in the [RESOURCE] Definition Group of items providing information about primary health condition(s) or disease(s) considered in the [RESOURCE]. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.conditions.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 nfdi4health-lm-mds-design-v3-3.Design.conditions.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.conditions.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 rim: N/A
label		1..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.conditions.label Short description Primary health condition or disease name Definition Name of primary health condition or disease considered in the [RESOURCE]. 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). / 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())` Examples Example of a condition or disease name SARS-CoV-2 Mappings rim: n/a
classification		1..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.conditions.classification Short description Terminology/classification Definition Terminology/classification used for the health condition or disease. Comments Short Input Help: If used, name of the terminology/classification. / Source of the property and/or allowed values: DRKS [3], DataCite [1] Data type Coding Binding NFDI4Health_VS_MDS_Study_Conditions_Classification_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of a terminology { "text": "SNOMED CT" } Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
code		0..1	uri	Element id nfdi4health-lm-mds-design-v3-3.Design.conditions.code Short description Code of the health condition or disease Definition Code of the health condition or disease in the terminology/classification used. Comments Short Input Help: If known, you can provide the code from the terminology/classification used. / Source of the property and/or allowed values: DataCite [1] Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of a code for a condition or disease http://snomed.info/id/840533007 Mappings rim: n/a
focus		0..*	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.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.). Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.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 nfdi4health-lm-mds-design-v3-3.Design.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.focus.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 rim: N/A
label		1..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.focus.label Short description Focus area Definition Focus area of the [RESOURCE] (e.g. medication, food, therapy, device, etc.). 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). / 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 rim: n/a
classification		1..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.focus.classification Short description Terminology/classification Definition Terminology/classification used for the focus area. Comments Short Input Help: If used, name of the terminology/classification. / Source of the property and/or allowed values: DRKS [3], DataCite [1] Data type Coding Binding NFDI4Health_VS_MDS_Study_Conditions_Classification_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of a terminology or classification { "text": "SNOMED CT" } Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
code		0..1	uri	Element id nfdi4health-lm-mds-design-v3-3.Design.focus.code Short description Code of the focus area Definition Code of the focus area in the terminology/classification used. Comments Short Input Help: If known, you can provide the code from the terminology/classification used. / Source of the property and/or allowed values: DataCite [1] Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples Example of a code for a focus area http://snomed.info/id/840533007 Mappings rim: n/a
groupsOfDiseases		1..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.groupsOfDiseases Short description Groups of diseases or conditions Definition Group of items providing information about groups of diseases or conditions on which the data were collected in the [RESOURCE]. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.groupsOfDiseases.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 nfdi4health-lm-mds-design-v3-3.Design.groupsOfDiseases.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.groupsOfDiseases.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 rim: N/A
generally		1..*	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.groupsOfDiseases.generally Short description Which groups of diseases or conditions were the data collected on? Definition General groups of diseases or conditions on which the data were collected in the [RESOURCE]. Comments Additional Information: The values originate from the WHO's International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). / Short Input Help: Select all that apply. For more information about the groups of diseases/conditions, visit the WHO's ICD-10 homepage: https://icd.who.int/en. / Source of the property and/or allowed values: ICD-10 [15] Data type Coding Binding NFDI4Health_VS_MDS_Study_Groups_Of_Diseases_Generally_ICD10_SCT (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
conditions		0..*	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.groupsOfDiseases.conditions Short description On which diseases or conditions were the data collected? Definition Diseases or conditions on which the data were collected in the [RESOURCE]. Comments Additional Information: The values originate from the WHO's International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). / Short Input Help: Select all that apply. Values are based on lower level ICD-10. For more information visit the WHO's ICD-10 homepage: https://icd.who.int/en. / Source of the property and/or allowed values: ICD-10 [15] (NFDI4Health UC 5.2 requirements) Data type Coding Binding NFDI4Health_VS_MDS_Study_Groups_Of_Diseases_Generally_Conditions_ICD (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
mortalityData		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.mortalityData Short description Collects mortality data? 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 / Source of the property and/or allowed values: NFDI4Health UC 5.2 requirements Data type Coding Binding NFDI4Health_VS_MDS_Mortality_Data_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
administrativeInformation		0..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.administrativeInformation Short description Administrative information about the [RESOURCE] Definition Group of items providing administrative information about the [RESOURCE]. Comments Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..1 / Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.administrativeInformation.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 nfdi4health-lm-mds-design-v3-3.Design.administrativeInformation.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.administrativeInformation.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 rim: N/A
ethicsCommitteeApproval		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.administrativeInformation.ethicsCommitteeApproval Short description Status of the ethics committee approval Definition Status of the [RESOURCE] approval from the (leading) ethics committee. Comments Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Study_Ethics_Committee_Approval_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
status		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.administrativeInformation.status Short description Overall [RESOURCE] status Definition Overall status of the [RESOURCE]. Comments Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0 / Additional Information: If at least one [RESOURCE] site in a multicenter [RESOURCE] has the status 'Ongoing', then the overall status of the [RESOURCE] must be 'Ongoing'. / 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_Overall_Status_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
statusWhenIntervention		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.administrativeInformation.statusWhenIntervention Short description Participants receive an intervention? Definition Specification whether [RESOURCE] participants receive an intervention or have completed it but are still being followed up according to the primary objective of the [RESOURCE]. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign == 'Interventional' AND Design.administrativeInformation.status == ('At the planning stage' OR 'Ongoing (I): Recruitment ongoing, but data collection not yet started' OR 'Ongoing (II): Recruitment and data collection ongoing' OR 'Ongoing (III): Recruitment completed, but data collection ongoing' OR 'Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing'); 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_When_Intervention_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
stageStopped		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.administrativeInformation.stageStopped Short description Stopping stage Definition Specification of the stage at which the [RESOURCE] was prematurely stopped. 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 rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
reasonStopped		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.administrativeInformation.reasonStopped Short description Stopping reason Definition Specification of the reason(s) why the [RESOURCE] was prematurely stopped. 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())` Examples Example of a stopping reason accrual goal met Mappings rim: n/a
statusEnrollingByInvitation		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.administrativeInformation.statusEnrollingByInvitation Short description Participants enrolled by invitation? Definition Specification whether [RESOURCE] participants are selected from a predetermined population. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Yes_No_Not_Applicable_SNOMEDCT (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
recruitmentStatusRegister		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.administrativeInformation.recruitmentStatusRegister Short description Overall recruitment status from the register of clinical trials Definition Overall recruitment status of the [RESOURCE] as indicated in the corresponding register of clinical trials. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Resource.provenance.dataSource != 'Manually collected'; otherwise 0..0 / Additional Information: The item applies only to studies automatically uploaded from the registers of clinical trials. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Study_Recruitment_Register_NCI_SCT_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
startDate		0..1	date	Element id nfdi4health-lm-mds-design-v3-3.Design.administrativeInformation.startDate Short description Start date Definition Start date of data collection for the [RESOURCE]. 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. / Source of the property and/or allowed values: CT.gov [2], DRKS [3], NFDI4Health Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
endDate		0..1	date	Element id nfdi4health-lm-mds-design-v3-3.Design.administrativeInformation.endDate Short description End date Definition 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. / Source of the property and/or allowed values: CT.gov [2], DRKS [3], NFDI4Health Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
centers		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.centers Short description Mono- or multicentric? Definition Specification whether the [RESOURCE] is conducted at only one or at more than one [RESOURCE] center. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0 / Source of the property and/or allowed values: DRKS [3], CT.gov [2] Data type Coding Binding NFDI4Health_VS_MDS_Study_Centers_SNOMEDCT_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
centersNumber		0..1	integer	Element id nfdi4health-lm-mds-design-v3-3.Design.centersNumber Short description Number of centers Definition Number of centers involved in the [RESOURCE]. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.centers == 'Multicentric'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health, DRKS [3], CT.gov [2] Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
dataProviders		0..1	CodeableConcept	Element id nfdi4health-lm-mds-design-v3-3.Design.dataProviders Short description One or more data providers? Definition Specification whether the [RESOURCE] involves only one or more than one data provider. Comments Cardinality: 0..1, if Resource.classification.type == ('Registry' OR 'Secondary data source'); otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.3 requirements Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
dataProvidersNumber		0..1	integer	Element id nfdi4health-lm-mds-design-v3-3.Design.dataProvidersNumber Short description Number of data providers Definition Number of data providers involved in the [RESOURCE]. Comments Cardinality: 0..1, if Resource.classification.type == ('Registry' OR 'Secondary data source') AND Design.dataProviders == 'Several data providers'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.3 requirements Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
subject		1..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.subject Short description Primary subject Definition The primary subject addressed by the [RESOURCE], i.e. a person, an animal or other subject types. Comments Short Input Help: Select one value from the list. / Source of the property and/or allowed values: NFDI4Health, DDI [4] Data type Coding Binding NFDI4Health_VS_MDS_Study_Subject_SNOMEDCT (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
sampling		0..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.sampling Short description Sampling method Definition Group of items providing information about the applied sampling method. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.sampling.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 nfdi4health-lm-mds-design-v3-3.Design.sampling.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.sampling.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 rim: N/A
method		1..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.sampling.method Short description Applied sampling method Definition Type of the sampling method applied for the selection of [RESOURCE] participants. Comments Short Input Help: Select one value from the list. / Source of the property and/or allowed values: DDI [12], NFDI4Health, CT.gov [2] Data type Coding Binding NFDI4Health_VS_MDS_Study_Sampling_Method_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
probabilityMethod		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.sampling.probabilityMethod Short description Specific type of probability sampling Definition Specific type of the probability sampling method applied for the selection of [RESOURCE] participants. Comments Cardinality: 0..1, if Design.sampling.method == 'Probability'; otherwise 0..0 / Short Input Help: If known, select one value from the list. / Source of the property and/or allowed values: NFDI4Health, DDI [12] Data type Coding Binding NFDI4Health_VS_MDS_Study_Sampling_Probability_Method_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
nonProbabilityMethod		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.sampling.nonProbabilityMethod Short description Specific type of non-probability sampling Definition Specific type of the non-probability sampling method applied for the selection of [RESOURCE] participants. Comments Cardinality: 0..1, if Design.sampling.method == 'Non-probability'; otherwise 0..0 / Short Input Help: If known, select one value from the list. / Source of the property and/or allowed values: NFDI4Health, DDI [12] Data type Coding Binding NFDI4Health_VS_MDS_Study_Sampling_Method_Non_Probability_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
dataSource		0..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSource Short description Data sources of the [RESOURCE] Definition Group of items providing information about data sources from which the data of the [RESOURCE] are generated or extracted. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.dataSource.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 nfdi4health-lm-mds-design-v3-3.Design.dataSource.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.dataSource.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 rim: N/A
general		0..*	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSource.general Short description Type(s) of data sources Definition Different types of data sources from which the data of the [RESOURCE] are generated or extracted. Comments Short Input Help: Select all that apply. / Source of the property and/or allowed values: NFDI4Health, Maelstrom [8], MIABIS [6] Data type Coding Binding NFDI4Health_VS_MDS_Study_Data_Sources_General_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
biosamples		0..*	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSource.biosamples Short description Biosamples collected Definition Specification of biosamples collected in the [RESOURCE]. Comments Cardinality: 0.., if Design.dataSource.general == 'Biological samples'; otherwise 0..0 / Short Input Help: Select all that apply. / Source of the property and/or allowed values: NFDI4Health, Maelstrom [8], MIABIS [6] Data type* Coding Binding NFDI4Health_VS_MDS_Study_DS_Biosamples_SCT_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
imaging		0..*	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSource.imaging Short description Imaging data collected Definition Specification of imaging data collected in the [RESOURCE]. Comments Cardinality: 0.., if Design.dataSource.general == 'Imaging data'; otherwise 0..0 / Short Input Help: Select all that apply. / Source of the property and/or allowed values: NFDI4Health, Maelstrom [8], MIABIS [6] Data type* Coding Binding NFDI4Health_VS_MDS_Study_Data_Sources_Imaging_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
omics		0..*	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSource.omics Short description Omics technology used Definition Specification of omics technology applied in the [RESOURCE]. Comments Cardinality: 0.., if Design.dataSource.general == 'Omics technology'; otherwise 0..0 / Short Input Help: Select all that apply. / Source of the property and/or allowed values: NFDI4Health, Maelstrom [8], MIABIS [6] Data type* Coding Binding NFDI4Health_VS_MDS_Study_Data_Sources_Omics_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
description		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSource.description Short description Additional information about data sources Definition If needed, additional descriptive information about the data sources of the [RESOURCE], e.g. indication of the data source(s) not listed in the field 'Type(s) of data sources' or a more detailed description of the selected data sources. Comments Short Input Help: You can indicate here other data source(s) not listed in the field 'Type(s) of data sources' or provide a more detailed description of the selected data sources. / Source of the property and/or allowed values: NFDI4Health Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
primaryPurpose		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.primaryPurpose Short description Primary purpose of the [RESOURCE] Definition Specification of the main purpose of the [RESOURCE]. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0 / 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. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type Coding Binding 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 rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
eligibilityCriteria		0..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria Short description Eligibility criteria for [RESOURCE] participants Definition Group of items providing information about eligibility criteria for [RESOURCE] participants. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.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 nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.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 rim: N/A
ageMin		0..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.ageMin Short description Eligibility criteria: Minimum age Definition Group of items providing information about the minimum eligible age of [RESOURCE] participants. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.ageMin.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 nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.ageMin.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.ageMin.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 rim: N/A
number		1..1	integer	Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.ageMin.number Short description Minimum eligible age Definition Numerical value of the minimum age of potential participants eligible to participate in the [RESOURCE]. Comments Additional Information: In the case of cohort studies, further participant ages can be indicated in the fields 'Inclusion criteria' or 'Exclusion criteria'. / Short Input Help: If age is less than 1 year, please indicate a value in months, weeks, days, hours, minutes, or weeks of gestation. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
timeUnit		1..1	Coding	Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.ageMin.timeUnit Short description Unit of age Definition Unit of measurement used to describe the minimum eligible age. Comments Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
ageMax		0..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.ageMax Short description Eligibility criteria: Maximum age Definition Group of items providing information about the maximum eligible age of [RESOURCE] participants. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.ageMax.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 nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.ageMax.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.ageMax.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 rim: N/A
number		1..1	integer	Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.ageMax.number Short description Maximum eligible age Definition Numerical value of the maximum age of potential participants eligible to participate in the [RESOURCE]. Comments Additional Information: In the case of cohort studies, further participant ages can be indicated in the fields 'Inclusion criteria' or 'Exclusion criteria'. / Short Input Help: If age is less than 1 year, please indicate a value in months, weeks, days, hours, minutes, or weeks of gestation. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
timeUnit		1..1	Coding	Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.ageMax.timeUnit Short description Unit of age Definition Unit of measurement used to describe the maximum eligible age. Comments Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
genders		0..*	Coding	Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.genders Short description Eligible gender Definition Gender of potential participants eligible to participate in the [RESOURCE]. Comments Short Input Help: Select all that apply. If no gender was explicitly excluded in the [RESOURCE], 'Male', 'Female', and 'Diverse' should be selected. / Source of the property and/or allowed values: CT.gov [2], DRKS [3], NFDI4Health Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
inclusionCriteria		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.inclusionCriteria Short description Inclusion criteria Definition Inclusion criteria for participation in the [RESOURCE]. Comments Short Input Help: If possible, use an enumerated or bulleted list for each criterion, starting with '-' and finishing with ';'. / 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())` Examples Example of a list of inclusion criteria '- First inclusion criterion; - Second inclusion criterion; Mappings rim: n/a
exclusionCriteria		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.eligibilityCriteria.exclusionCriteria Short description Exclusion criteria Definition Exclusion criteria for participation in the [RESOURCE]. Comments Short Input Help: If possible, use an enumerated or bulleted list for each criterion, starting with '-' and finishing with ';'. / 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())` Examples Example of a list of exclusion criteria '- First inclusion criterion; - Second inclusion criterion; Mappings rim: n/a
population		1..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.population Short description Population of the [RESOURCE] Definition Group of items providing information about the population of the [RESOURCE]. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.population.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 nfdi4health-lm-mds-design-v3-3.Design.population.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.population.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 rim: N/A
coverage		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.population.coverage Short description Coverage Definition Specification of the recruitment area of the [RESOURCE]. Comments Short Input Help: Select one value from the list. / Source of the property and/or allowed values: NFDI4Health Data type Coding Binding NFDI4Health_VS_MDS_Population_Coverage_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
countries		1..*	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.population.countries Short description Country(ies) Definition Country or countries where the [RESOURCE] takes place. Comments Short Input Help: Select all that apply. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Countries_ISO (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
region		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.population.region Short description Region(s) and/or city(ies) Definition If applicable, region(s) and/or city(ies) within a country where the [RESOURCE] takes place. Comments Source of the property and/or allowed values: NFDI4Health Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
description		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.population.description Short description Population description Definition Additional descriptive information providing more details about the population of the [RESOURCE]. Comments Short Input Help: Any information important for the given [RESOURCE] population can be specified here. / Source of the property and/or allowed values: CT.gov [2], Maelstrom [8] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
targetSampleSize		0..1	integer	Element id nfdi4health-lm-mds-design-v3-3.Design.population.targetSampleSize Short description Target sample size Definition Intended number of observational units for the whole [RESOURCE] (e.g. intended number of [RESOURCE] participants at all sites of the [RESOURCE]). Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0 / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
obtainedSampleSize		0..1	integer	Element id nfdi4health-lm-mds-design-v3-3.Design.population.obtainedSampleSize Short description Obtained sample size Definition Obtained number of observational units for the whole [RESOURCE] (e.g. obtained number of [RESOURCE] participants at all sites of the [RESOURCE]). Comments Additional Information: The value is only available after the end of recruitment. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
hypotheses		0..*	string	Element id nfdi4health-lm-mds-design-v3-3.Design.hypotheses Short description Research questions/hypotheses Definition Statement of the research questions and/or hypotheses underlying the [RESOURCE]. Comments Cardinality: 0.., if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health, ISRCTN [16] Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
arms		0..*	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.arms Short description Arms of the [RESOURCE] Definition Group of items providing information about the arms of the [RESOURCE]. Comments Cardinality: 0.., if Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign == 'Interventional'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health Data type* BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.arms.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 nfdi4health-lm-mds-design-v3-3.Design.arms.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.arms.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 rim: N/A
label		1..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.arms.label Short description Name of the arm Definition Short name used to identify the arm. Comments Additional Information: Arm' means a pre-specified group or subgroup of participants in the [RESOURCE] assigned to receive specific intervention(s) (or no intervention) according to a protocol. / Source of the property and/or allowed values: CT.gov [2] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
type		1..1	Coding	Element id nfdi4health-lm-mds-design-v3-3.Design.arms.type Short description Role of the arm Definition Role of the given arm in the [RESOURCE]. Comments Short Input Help: Select one value from the list. / Source of the property and/or allowed values: CT.gov [2] Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
description		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.arms.description Short description Additional information about the arm Definition Additional descriptive information about the given arm. Comments Additional Information: If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the [RESOURCE]. / 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 rim: n/a
groups		0..*	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.groups Short description Groups/cohorts of the [RESOURCE] Definition Group of items providing information about the groups/cohorts of the [RESOURCE]. Comments Cardinality: 0.., if Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign == 'Non-interventional'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health Data type* BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.groups.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 nfdi4health-lm-mds-design-v3-3.Design.groups.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.groups.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 rim: N/A
label		1..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.groups.label Short description Name of the group Definition Short name used to identify the group. Comments Additional Information: Group' means a predefined group (cohort) of participants to be studied. / Source of the property and/or allowed values: CT.gov [2] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
description		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.groups.description Short description Additional information about the group Definition Additional descriptive information about the given group. Comments Additional Information: Explanation of the nature of the [RESOURCE] group (for example, participants with and without a condition, participants with and without an exposure, 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 rim: n/a
interventions		0..*	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.interventions Short description Interventions of the [RESOURCE] Definition Group of items providing information about the interventions of the [RESOURCE]. Comments Cardinality: 0.., if Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign == 'Interventional'; otherwise 0..0 / Additional Information: Specification of the intervention(s) associated with each arm. / Source of the property and/or allowed values: NFDI4Health Data type* BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.interventions.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 nfdi4health-lm-mds-design-v3-3.Design.interventions.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.interventions.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 rim: N/A
name		1..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.interventions.name Short description Name of the intervention Definition A short descriptive name of the intervention. Comments Short Input Help: If the same intervention is associated with more than one arm, please provide the information once and use the field 'Name(s) of the arm(s) associated with the given intervention' to associate it with more than one arm. / Source of the property and/or allowed values: CT.gov [2] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
type		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.interventions.type Short description Type of the intervention Definition General type of the given intervention. Comments Source of the property and/or allowed values: CT.gov [2] Data type Coding Binding NFDI4Health_VS_MDS_Study_Intervention_Type_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
description		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.interventions.description Short description Additional information about the intervention Definition If needed, additional descriptive information about the given intervention. Comments Source of the property and/or allowed values: CT.gov [2] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
armsLabel		0..*	string	Element id nfdi4health-lm-mds-design-v3-3.Design.interventions.armsLabel Short description Name(s) of the arm(s) associated with the given intervention Definition Name(s) of the [RESOURCE] arm(s) associated with the given intervention. Comments Source of the property and/or allowed values: CT.gov [2] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
exposures		0..*	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.exposures Short description Exposures of the [RESOURCE] Definition Group of items providing information about the exposures of the [RESOURCE]. Comments Cardinality: 0.., if (Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign == 'Non-interventional') OR Resource.classification.type == ('Registry' OR 'Secondary data source'); otherwise 0..0 / Additional Information: Specification of the exposure(s) associated with each group. / Source of the property and/or allowed values: NFDI4Health Data type* BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.exposures.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 nfdi4health-lm-mds-design-v3-3.Design.exposures.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.exposures.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 rim: N/A
name		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.exposures.name Short description Name of the exposure Definition A short descriptive name of the exposure. Comments Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0 / Short Input Help: If the same exposure is associated with more than one group, please provide the information once and use the field 'Name(s) of the group(s) associated with the given exposure' to associate it with more than one group. / Source of the property and/or allowed values: CT.gov [2] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
type		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.exposures.type Short description Type of the exposure Definition General type of the given exposure. Comments Source of the property and/or allowed values: CT.gov [2] Data type Coding Binding NFDI4Health_VS_MDS_Study_Exposure_Type_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
description		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.exposures.description Short description Additional information about the exposure Definition If needed, additional descriptive information about the given exposure. Comments Source of the property and/or allowed values: CT.gov [2] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
groupsLabel		0..*	string	Element id nfdi4health-lm-mds-design-v3-3.Design.exposures.groupsLabel Short description Name(s) of the group(s) associated with the given exposure Definition Name(s) of the [RESOURCE] group(s) associated with the given exposure. Comments Cardinality: 0.., if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0 / Source of the property and/or allowed values: CT.gov [2] Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
outcomes		0..*	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.outcomes Short description Outcome measures in the [RESOURCE] Definition Group of items providing information about outcome measures. Comments Additional Information: The items are optional, especially for non-interventional studies. / Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.outcomes.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 nfdi4health-lm-mds-design-v3-3.Design.outcomes.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.outcomes.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 rim: N/A
title		1..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.outcomes.title Short description Name of the outcome measure Definition Name of the outcome measure. For non-interventional studies, this can be the name of specific measurement(s) or observation(s) used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. Comments Short Input Help: For non-interventional studies, you can provide specific measurement(s) or observation(s) used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. / Source of the property and/or allowed values: CT.gov [2] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
description		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.outcomes.description Short description Description of the outcome measure Definition Additional descriptive information about the given outcome. Comments 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 rim: n/a
type		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.outcomes.type Short description Type of the outcome measure Definition The type indicates the degree of importance of the outcome measure in the [RESOURCE]. Comments Cardinality: 1..1, if (Design.outcomes.title != Null OR Design.outcomes.description != Null); otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3] Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Outcome_Type_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
timeFrame		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.outcomes.timeFrame Short description Time point(s) of assessment Definition Description of the time point(s) at which the measurement for the outcome is assessed, e.g. the specific duration of time over which each participant is assessed. Comments Source of the property and/or allowed values: CT.gov [2] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
comment		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.comment 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. / Source of the property and/or allowed values: NFDI4Health Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
assessments		0..*	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.assessments Short description Additional assessments/measurements in the [RESOURCE] Definition Any additional assessments/measurements included in the [RESOURCE]. Comments Short Input Help: Select all that apply. / Source of the property and/or allowed values: NFDI4Health, ENPADASI [17] Data type Coding Binding NFDI4Health_VS_MDS_Study_Assessments_SCT_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
dataSharingPlan		1..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSharingPlan Short description Data sharing strategy of the [RESOURCE] Definition Group of items providing information about the data sharing strategy of the [RESOURCE]. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.dataSharingPlan.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 nfdi4health-lm-mds-design-v3-3.Design.dataSharingPlan.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.dataSharingPlan.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 rim: N/A
generally		1..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSharingPlan.generally Short description Is it planned to share the data? Definition Indication whether there is a plan to make data collected in the [RESOURCE] available. In case of a [RESOURCE] with patients or other individuals, this refers to individual participant data (IPD). Comments Short Input Help: Select one value from the list. / Source of the property and/or allowed values: Taichman DB, et al. [5], CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Yes_No_Undecided_SNOMEDCT_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
supportingInformation		0..*	Coding	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSharingPlan.supportingInformation Short description Supporting documents available in addition to the data Definition Supporting information/documents which will be made available in addition to the data collected in the [RESOURCE]. Comments Cardinality: 0.., if Design.dataSharingPlan.generally == 'Yes, there is a plan to make data available'; otherwise 0..0 / Short Input Help: Select all that apply. / Source of the property and/or allowed values: Taichman DB, et al. [5], CT.gov [2] Data type* Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
timeFrame		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSharingPlan.timeFrame Short description When and for how long will the data be available? Definition Indication of the time period for which the data and, if applicable, supporting documents will be made available. Comments Cardinality: 0..1, if Design.dataSharingPlan.generally == 'Yes, there is a plan to make data available'; otherwise 0..0 / Source of the property and/or allowed values: Taichman DB, et al. [5], CT.gov [2] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
accessCriteria		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSharingPlan.accessCriteria Short description Criteria for data access Definition Indication of the access criteria by which the data will be shared, including: a) with whom; b) for which types of analyses; and c) by what mechanism. Comments 0..1, if Design.dataSharingPlan.generally == 'Yes, there is a plan to make data available'; otherwise 0..0 / Short Input Help: Please provide here with whom, for which types of analyses and by what mechanism the data will be shared. / Source of the property and/or allowed values: Taichman DB, et al. [5], CT.gov [2] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
description		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSharingPlan.description Short description Additional information about data sharing Definition Additional descriptive information providing more details about data sharing, e.g. indication of which data in particular will be shared or why the data will not be shared or why it is not yet decided. Comments Short Input Help: Please indicate here which data in particular will be shared, or the reasons why it will not be shared or it is not yet decided. / Source of the property and/or allowed values: Taichman DB, et al. [5], 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 rim: n/a
datashield		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSharingPlan.datashield Short description DataSHIELD/Opal infrastructure available? Definition Indication whether the DataSHIELD/Opal infrastructure is available. Comments Source of the property and/or allowed values: NFDI4Health Data type Coding Binding NFDI4Health_VS_MDS_Study_Data_Sharing_Plan_Datashield_SCT_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
requestData		0..1	url	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSharingPlan.requestData Short description Link to data request application Definition If existing, a link to the web page where the data request form and/or information on data reuse can be found. Comments Source of the property and/or allowed values: NFDI4Health Data type url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
url		0..1	url	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSharingPlan.url Short description Web page with additional information about data sharing Definition If existing, a link to the web page where additional information about data sharing can be found. Comments Source of the property and/or allowed values: Taichman DB, et al. [5], CT.gov [2] Data type url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
recordLinkage		0..1	boolean	Element id nfdi4health-lm-mds-design-v3-3.Design.dataSharingPlan.recordLinkage Short description Record linkage possible? Definition Indication if record linkage with other data sources is possible. Comments Cardinality: 1..1, if Resource.provenance.dataSource == 'Manually collected'; otherwise 0..0 / Additional Information: Record linkage refers to the merging of data on the same person from different databases. / Source of the property and/or allowed values: NFDI4Health UC 5.3 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
nonInterventional		0..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.nonInterventional Short description Non-interventional aspects of the [RESOURCE] Definition Group of items providing information about specific non-interventional aspects of the [RESOURCE]. Comments Cardinality: 0..1, if (Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign == 'Non-interventional') OR Resource.classification.type == ('Registry' OR 'Secondary data source'); otherwise 0..0 / Additional Information: Group of items applicable only to non-interventional resources. / Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.nonInterventional.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 nfdi4health-lm-mds-design-v3-3.Design.nonInterventional.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.nonInterventional.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 rim: N/A
timePerspectives		0..*	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.nonInterventional.timePerspectives Short description Temporal design Definition Temporal design of the [RESOURCE], i.e. the observation period in relation to the time of participant enrollment. Comments Cardinality: 0.., if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0 / Short Input Help: Is it a retrospective, prospective or cross-sectional [RESOURCE]? / Source of the property and/or allowed values: CT.gov [2] Data type* Coding Binding NFDI4Health_VS_MDS_Study_Time_Perspectives_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
targetFollowUpDuration		0..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.nonInterventional.targetFollowUpDuration Short description Target follow-up duration of the [RESOURCE] Definition If applicable, anticipated time period over which each participant would be followed. Comments Source of the property and/or allowed values: CT.gov [2] Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.nonInterventional.targetFollowUpDuration.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 nfdi4health-lm-mds-design-v3-3.Design.nonInterventional.targetFollowUpDuration.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.nonInterventional.targetFollowUpDuration.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 rim: N/A
number		1..1	integer	Element id nfdi4health-lm-mds-design-v3-3.Design.nonInterventional.targetFollowUpDuration.number Short description Target follow-up duration Definition Numerical value of the target follow-up duration. Comments Source of the property and/or allowed values: CT.gov [2] Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
timeUnit		1..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.nonInterventional.targetFollowUpDuration.timeUnit Short description Unit of time Definition Unit of measurement used to describe the follow-up duration. Comments Source of the property and/or allowed values: CT.gov [2] Data type Coding Binding NFDI4Health_VS_MDS_Time_Units_UCUM (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
frequency		0..1	integer	Element id nfdi4health-lm-mds-design-v3-3.Design.nonInterventional.targetFollowUpDuration.frequency Short description Number of follow-ups conducted Definition The number of follow-ups conducted within the specified duration. Comments Source of the property and/or allowed values: NFDI4Health Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
biospecimenRetention		0..*	Coding	Element id nfdi4health-lm-mds-design-v3-3.Design.nonInterventional.biospecimenRetention Short description Biosamples retained in a biorepository Definition Indication whether samples of biomaterials from participants of the [RESOURCE] are retained in a biorepository. Comments Short Input Help: Select all that apply. / Source of the property and/or allowed values: CT.gov [2] Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
biospecimenDescription		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.nonInterventional.biospecimenDescription Short description Specific types of retained biosamples Definition Additional information about retained biosamples, i.e. an indication of the specific types of retained biospecimens (e.g. blood, serum, urine, etc.). Comments Cardinality: 0..1, if Design.nonInterventional.biospecimenRetention != 'None retained'; otherwise 0..0 / Short Input Help: You can provide here specific types of retained biosamples (e.g. blood, serum, urine, etc.). / Source of the property and/or allowed values: CT.gov [2] 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 retained biosample blood Mappings rim: n/a
interventional		0..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.interventional Short description Interventional aspects of the [RESOURCE] Definition Group of items providing information about specific interventional aspects of the [RESOURCE]. Comments Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign =='Interventional'; otherwise 0..0 / Additional Information: Group of items applicable only to interventional resources. / Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.interventional.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 nfdi4health-lm-mds-design-v3-3.Design.interventional.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.interventional.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 rim: N/A
phase		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.interventional.phase Short description Numerical phase Definition If applicable, numerical phase of the [RESOURCE]. Comments Short Input Help: Select one value from the list. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type Coding Binding 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 rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
masking		0..1	BackboneElement	Element id nfdi4health-lm-mds-design-v3-3.Design.interventional.masking Short description Masking of intervention(s) assignment Definition Group of items providing information about the masking of intervention(s) assignment. Comments Source of the property and/or allowed values: NFDI4Health Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.interventional.masking.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 nfdi4health-lm-mds-design-v3-3.Design.interventional.masking.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design-v3-3.Design.interventional.masking.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 rim: N/A
general		0..1	boolean	Element id nfdi4health-lm-mds-design-v3-3.Design.interventional.masking.general Short description Masking implemented? Definition Indication whether a masking (or blinding) of intervention(s) assignment is implemented (i.e., whether someone is prevented from having knowledge of the interventions assigned to individual participants). Comments Source of the property and/or allowed values: CT.gov [2], DRKS [3], NFDI4Health Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
roles		0..*	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.interventional.masking.roles Short description Who is masked? Definition If masking is implemented, the party(ies) who are masked. Comments Cardinality: 0.., if Design.interventional.masking.general == true; otherwise 0..0 / Short Input Help: Select all that apply. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type* Coding Binding NFDI4Health_VS_MDS_Study_Masking_Roles_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
description		0..1	string	Element id nfdi4health-lm-mds-design-v3-3.Design.interventional.masking.description Short description Additional information about masking Definition If needed, additional descriptive information about masking (e.g. information about other parties who may be masked). Comments Cardinality: 0..1, if Design.interventional.masking.general == true; otherwise 0..0 / Short Input Help: You can provide here additional information about masking, e.g. other parties who may be masked. / Source of the property and/or allowed values: CT.gov [2] Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
allocation		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.interventional.allocation Short description Type of allocation of participants to an arm Definition Type of allocation/assignment of individual participants of the [RESOURCE] to an arm. Comments Short Input Help: Select one value from the list. / Source of the property and/or allowed values: CT.gov [2], DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Study_Allocation_NCI (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
offLabelUse		0..1	CodingBinding	Element id nfdi4health-lm-mds-design-v3-3.Design.interventional.offLabelUse Short description Off-label use of a drug product Definition Unapproved (off-label) use of a drug product. Comments Short Input Help: Select 'Yes' or 'No' only for a drug [RESOURCE] and 'Not applicable' for any other [RESOURCE]. / Source of the property and/or allowed values: DRKS [3] Data type Coding Binding NFDI4Health_VS_MDS_Yes_No_Not_Applicable_SNOMEDCT (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding

Specific MDS modules

Nutritional Epidemiology

nfdi4health-lm-metadataschema-ne-v3-3			nfdi4health-lm-metadataschema-ne-v3-3	Element id nfdi4health-lm-metadataschema-ne-v3-3 Short description NFDI4Health LM Nutritional Epidemiology Metadataschema (UC 5.1) Definition NFDI4Health LogicalModel Nutritional Epidemiology Metadataschema (Use Case 5.1) V3.3 Data type nfdi4health-lm-metadataschema-ne-v3-3 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-metadataschema-ne-v3-3.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 nfdi4health-lm-metadataschema-ne-v3-3.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 rim: N/A
DietAssessment		0..*	BackboneElement	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment Short description Diet assessment information collected in the [RESOURCE] Definition Group of items providing information on diet assessment. Comments Cardinality: 1.., if Resource.nutritionalData == 'Yes'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type* BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.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 nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.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 rim: N/A
instrument		1..1	CodingBinding	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.instrument Short description Dietary assessment instrument used Definition Specification of the dietary assessment instrument used in the [RESOURCE]. Comments Short Input Help: Select one value from the list. / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type Coding Binding NFDI4Health_VS_MDS_NE_Instrument_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
ffqItemsNumber		0..1	integer	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.ffqItemsNumber Short description Number of items in FFQ Definition The number of items inquired by the food frequency questionnaire (FFQ). Comments Cardinality: 1..1, if DietAssessment.instrument == 'Food frequency questionnaire (FFQ)'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
mode		1..*	CodingBinding	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.mode Short description Mode(s) used to apply the dietary assessment instrument Definition Specification of how the dietary assessment instrument was applied to participants of the [RESOURCE]. Comments Short Input Help: Select all that apply. / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type Coding Binding NFDI4Health_VS_MDS_NE_Mode_NCI_MSH_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
device		1..*	CodingBinding	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.device Short description Device(s) used to apply the dietary assessment instrument Definition Specification of device(s) used to apply the dietary assessment instrument to participants of the [RESOURCE]. Comments Short Input Help: Select all that apply. / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type Coding Binding NFDI4Health_VS_MDS_NE_Device_NCI_SNOMEDCT_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
portionSizeEstimation		1..*	CodingBinding	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.portionSizeEstimation Short description Portion size estimated by: Definition Specification of how the portion size is inquired in the dietary assessment instrument. Comments Short Input Help: Select all that apply. / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type Coding Binding NFDI4Health_VS_MDS_NE_Portion_Size_SNOMEDCT_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
referencePeriodUnit		1..1	CodingBinding	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.referencePeriodUnit Short description Reference period unit Definition Indication of the reference period the dietary assessment instrument refers to (e.g. 24-h recall refers to the previous day). Comments Short Input Help: Select all that apply. / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type Coding Binding NFDI4Health_VS_MDS_NE_Reference_Period_Unit_UCUM (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
referencePeriodNumber		1..1	integer	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.referencePeriodNumber Short description Numerical value of reference period units Definition Numerical value of reference period units Comments Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
repeat		1..1	boolean	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.repeat Short description Instrument applied repeatedly? Definition Indication whether the same instrument was applied repeatedly. Comments Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
repeatFrequency		0..1	integer	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.repeatFrequency Short description Frequency of instrument application Definition Indication of how often the dietary assessment instrument was repeatedly applied. Comments Cardinality: 1..1, if DietAssessment.repeat == 'Yes'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
validity		1..1	boolean	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.validity Short description Instrument validated? Definition Indication whether the dietary assessment instrument was validated. Comments Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
validityReference		0..1	string	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.validityReference Short description Reference describing the validation Definition Indication of the reference describing the validation. Comments Cardinality: 1..1, if DietAssessment.validity == 'Yes'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
reliability		1..1	boolean	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.reliability Short description Instrument described according to reliability? Definition Indication whether the dietary assessment instrument was described according to its reliability. Comments Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
reliabilityReference		0..1	string	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.reliabilityReference Short description Reference describing reliability measures Definition Indication of the reference describing the reliability measures. Comments Cardinality: 1..1, if DietAssessment.reliability == 'Yes'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
dietarySupplements		1..1	boolean	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.dietarySupplements Short description Dietary supplements inquired? Definition Indication whether the dietary assessment instrument inquires information about dietary supplements. Comments Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a

Epidemiology of Chronic Diseases

nfdi4health-lm-metadataschema-ne-v3-3			nfdi4health-lm-metadataschema-ne-v3-3	Element id nfdi4health-lm-metadataschema-ne-v3-3 Short description NFDI4Health LM Nutritional Epidemiology Metadataschema (UC 5.1) Definition NFDI4Health LogicalModel Nutritional Epidemiology Metadataschema (Use Case 5.1) V3.3 Data type nfdi4health-lm-metadataschema-ne-v3-3 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-metadataschema-ne-v3-3.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 nfdi4health-lm-metadataschema-ne-v3-3.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 rim: N/A
DietAssessment		0..*	BackboneElement	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment Short description Diet assessment information collected in the [RESOURCE] Definition Group of items providing information on diet assessment. Comments Cardinality: 1.., if Resource.nutritionalData == 'Yes'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type* BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.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 nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.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 rim: N/A
instrument		1..1	CodingBinding	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.instrument Short description Dietary assessment instrument used Definition Specification of the dietary assessment instrument used in the [RESOURCE]. Comments Short Input Help: Select one value from the list. / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type Coding Binding NFDI4Health_VS_MDS_NE_Instrument_NCI_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
ffqItemsNumber		0..1	integer	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.ffqItemsNumber Short description Number of items in FFQ Definition The number of items inquired by the food frequency questionnaire (FFQ). Comments Cardinality: 1..1, if DietAssessment.instrument == 'Food frequency questionnaire (FFQ)'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
mode		1..*	CodingBinding	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.mode Short description Mode(s) used to apply the dietary assessment instrument Definition Specification of how the dietary assessment instrument was applied to participants of the [RESOURCE]. Comments Short Input Help: Select all that apply. / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type Coding Binding NFDI4Health_VS_MDS_NE_Mode_NCI_MSH_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
device		1..*	CodingBinding	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.device Short description Device(s) used to apply the dietary assessment instrument Definition Specification of device(s) used to apply the dietary assessment instrument to participants of the [RESOURCE]. Comments Short Input Help: Select all that apply. / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type Coding Binding NFDI4Health_VS_MDS_NE_Device_NCI_SNOMEDCT_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
portionSizeEstimation		1..*	CodingBinding	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.portionSizeEstimation Short description Portion size estimated by: Definition Specification of how the portion size is inquired in the dietary assessment instrument. Comments Short Input Help: Select all that apply. / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type Coding Binding NFDI4Health_VS_MDS_NE_Portion_Size_SNOMEDCT_Local (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
referencePeriodUnit		1..1	CodingBinding	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.referencePeriodUnit Short description Reference period unit Definition Indication of the reference period the dietary assessment instrument refers to (e.g. 24-h recall refers to the previous day). Comments Short Input Help: Select all that apply. / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type Coding Binding NFDI4Health_VS_MDS_NE_Reference_Period_Unit_UCUM (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
referencePeriodNumber		1..1	integer	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.referencePeriodNumber Short description Numerical value of reference period units Definition Numerical value of reference period units Comments Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
repeat		1..1	boolean	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.repeat Short description Instrument applied repeatedly? Definition Indication whether the same instrument was applied repeatedly. Comments Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
repeatFrequency		0..1	integer	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.repeatFrequency Short description Frequency of instrument application Definition Indication of how often the dietary assessment instrument was repeatedly applied. Comments Cardinality: 1..1, if DietAssessment.repeat == 'Yes'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
validity		1..1	boolean	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.validity Short description Instrument validated? Definition Indication whether the dietary assessment instrument was validated. Comments Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
validityReference		0..1	string	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.validityReference Short description Reference describing the validation Definition Indication of the reference describing the validation. Comments Cardinality: 1..1, if DietAssessment.validity == 'Yes'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
reliability		1..1	boolean	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.reliability Short description Instrument described according to reliability? Definition Indication whether the dietary assessment instrument was described according to its reliability. Comments Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
reliabilityReference		0..1	string	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.reliabilityReference Short description Reference describing reliability measures Definition Indication of the reference describing the reliability measures. Comments Cardinality: 1..1, if DietAssessment.reliability == 'Yes'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
dietarySupplements		1..1	boolean	Element id nfdi4health-lm-metadataschema-ne-v3-3.DietAssessment.dietarySupplements Short description Dietary supplements inquired? Definition Indication whether the dietary assessment instrument inquires information about dietary supplements. Comments Source of the property and/or allowed values: NFDI4Health UC 5.1 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a

Record Linkage

nfdi4health-lm-metadataschema-recordlinkage			nfdi4health-lm-metadataschema-recordlinkage	Element id nfdi4health-lm-metadataschema-recordlinkage Short description Information about record linkage for the [RESOURCE] Definition Group of items providing information on record linkage. Data type nfdi4health-lm-metadataschema-recordlinkage Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-metadataschema-recordlinkage.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 nfdi4health-lm-metadataschema-recordlinkage.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 rim: N/A
RecordLinkage		0..1	BackboneElement	Element id nfdi4health-lm-metadataschema-recordlinkage.RecordLinkage Short description Information about record linkage for the [RESOURCE] Definition Group of items providing information on record linkage. Comments Cardinality: 1..1, if Design.dataSharingPlan.recordLinkage == 'Yes'; otherwise 0..0 / Source of the property and/or allowed values: NFDI4Health UC 5.3 requirements Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-metadataschema-recordlinkage.RecordLinkage.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 nfdi4health-lm-metadataschema-recordlinkage.RecordLinkage.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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-metadataschema-recordlinkage.RecordLinkage.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 rim: N/A
legalBasis		0..1	boolean	Element id nfdi4health-lm-metadataschema-recordlinkage.RecordLinkage.legalBasis Short description Legal regulation/permission for record linkage Definition Indication whether there are specific regulations/permissions for record linkage. Comments Additional information: Whether any specific legal regulations/permissions exist (e.g. for social data, for cancer registry data, hospital data, etc.). / Source of the property and/or allowed values: NFDI4Health UC 5.3 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
legalBasisDetails		0..1	string	Element id nfdi4health-lm-metadataschema-recordlinkage.RecordLinkage.legalBasisDetails Short description Specific legal basis allowing record linkage Definition Information specifying which specific legal basis allows for record linkage. Comments Cardinality: 1..1, if RecordLinkage.legalBasis == 'Yes'; otherwise 0..0 / Additional information:If existing, any specific legal regulations/permissions (e.g. for social data, for cancer registry data, hospital data, etc.). / Source of the property and/or allowed values: NFDI4Health UC 5.3 requirements Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
informedConsent		0..1	boolean	Element id nfdi4health-lm-metadataschema-recordlinkage.RecordLinkage.informedConsent Short description Informed consent for record linkage Definition Indication whether an informed consent that allows record linkage has been obtained. Comments Source of the property and/or allowed values: NFDI4Health UC 5.3 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
responsibleInstitutions		0..*	string	Element id nfdi4health-lm-metadataschema-recordlinkage.RecordLinkage.responsibleInstitutions Short description Responsible authorities Definition Institutions and authorities that must agree to the record linkage. Comments Source of the property and/or allowed values: NFDI4Health UC 5.3 requirements Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
additionalCosts		0..1	boolean	Element id nfdi4health-lm-metadataschema-recordlinkage.RecordLinkage.additionalCosts Short description Additional costs for record linkage Definition Indication whether there are additional costs for record linkage. Comments Source of the property and/or allowed values: NFDI4Health UC 5.3 requirements Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
identifiers		0..*	string	Element id nfdi4health-lm-metadataschema-recordlinkage.RecordLinkage.identifiers Short description Identifiers for record linkage Definition Identifiers that can be used for record linkage (e.g. names, date of birth, zip code, insurance number or control number as in cancer registries). Comments Source of the property and/or allowed values: NFDI4Health UC 5.3 requirements Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
furtherDetails		0..1	string	Element id nfdi4health-lm-metadataschema-recordlinkage.RecordLinkage.furtherDetails Short description Further details important for conducting record linkage Definition Additional important details for conducting record linkage. Comments Source of the property and/or allowed values: NFDI4Health UC 5.3 requirements Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
exampleResources		0..*	string	Element id nfdi4health-lm-metadataschema-recordlinkage.RecordLinkage.exampleResources Short description Record linkage example resources Definition DOIs of additional related resources specific to record linkage (e.g., publications). Comments Short Input Help: Please do not repeat those already entered in the section 'Related resources'. / Source of the property and/or allowed values: NFDI4Health UC 5.3 requirements Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a