| MII_PR_MTB_Studie (ResearchStudy) | C | | MII_PR_Studie_Studie | There are no (further) constraints on this element Element idResearchStudy Short descriptionInvestigation to increase healthcare-related patient-independent knowledge Alternate namesClinical Trial, Study DefinitionA process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
Need to make sure we encompass public health studies.
MII_PR_Studie_Studie Constraints- dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
contained.contained.empty() - dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() - dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() - dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
contained.meta.security.empty() - dom-6: A resource should have narrative for robust management
text.`div`.exists()
Mappings- rim: Entity. Role, or Act
- BRIDG5.1: ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion
- v2: OBX
- rim: Observation[classCode=CLNTRL, moodCode=EVN]
|
| id | Σ | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.id Short descriptionLogical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
string |
| meta | S Σ | 0..1 | Meta | There are no (further) constraints on this element Element idResearchStudy.meta Short descriptionMetadata about the resource DefinitionThe metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
Meta Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.meta.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.meta.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
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.
Extension SlicingUnordered, 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 |
| versionId | Σ | 0..1 | id | There are no (further) constraints on this element Element idResearchStudy.meta.versionId Short descriptionVersion specific identifier DefinitionThe version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.
The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.
id Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
|
| lastUpdated | Σ | 0..1 | instant | There are no (further) constraints on this element Element idResearchStudy.meta.lastUpdated Short descriptionWhen the resource version last changed DefinitionWhen the resource last changed - e.g. when the version changed.
This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.
instant Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
|
| source | Σ | 0..1 | uri | There are no (further) constraints on this element Element idResearchStudy.meta.source Short descriptionIdentifies where the resource comes from DefinitionA uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.
In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.
This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.
uri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
|
| profile | S Σ | 0..* | canonical(StructureDefinition) | There are no (further) constraints on this element Element idResearchStudy.meta.profile Short descriptionProfiles this resource claims to conform to DefinitionCommentsIt is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.
canonical(StructureDefinition) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
|
| security | Σ | 0..* | CodingBinding | There are no (further) constraints on this element Element idResearchStudy.meta.security Short descriptionSecurity Labels applied to this resource DefinitionSecurity labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.
The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.
Coding BindingSecurity Labels from the Healthcare Privacy and Security Classification System.
All Security Labels (extensible) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
|
| tag | Σ | 0..* | Coding | There are no (further) constraints on this element Element idResearchStudy.meta.tag Short descriptionTags applied to this resource DefinitionTags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.
The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.
Coding BindingCodes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
CommonTags (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
|
| implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idResearchStudy.implicitRules Short descriptionA set of rules under which this content was created DefinitionA reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
uri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
|
| language | | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchStudy.language Short descriptionLanguage of the resource content DefinitionThe base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
code BindingCommonLanguages (preferred) Binding extensionsConstraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
|
| text | | 0..1 | Narrative | There are no (further) constraints on this element Element idResearchStudy.text Short descriptionText summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
Narrative Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
| contained | | 0..* | Resource | There are no (further) constraints on this element Element idResearchStudy.contained Short descriptionContained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
Resource Mappings |
| extension | S C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
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.
Extension SlicingUnordered, Open, by url(Value) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()
Mappings |
| Label | S C | 0..* | Extension(Complex) | There are no (further) constraints on this element Element idResearchStudy.extension:Label Short descriptionMII EX Studie Backport Label Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources.
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.
Extension(Complex) Extension URLhttp://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 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 |
| AssociatedParty | S C | 0..* | Extension(Complex) | There are no (further) constraints on this element Element idResearchStudy.extension:AssociatedParty Short descriptionMII EX Studie Backport AssociatedParty Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources.
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.
Extension(Complex) Extension URLhttp://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 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 |
| Ethikvotum | S C | 0..* | Extension(Complex) | There are no (further) constraints on this element Element idResearchStudy.extension:Ethikvotum Short descriptionMII EX Studie Ethikvotum Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources.
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.
Extension(Complex) Extension URLhttps://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 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 |
| Studienregister | S C | 0..* | Extension(Reference(Library)) | There are no (further) constraints on this element Element idResearchStudy.extension:Studienregister Short descriptionMII EX Studie Studienregister Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources.
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.
Extension(Reference(Library)) Extension URLhttps://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 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 |
| Eligibility | S C | 0..1 | Extension(Reference(Group | EvidenceVariable)) | There are no (further) constraints on this element Element idResearchStudy.extension:Eligibility Short descriptionMII EX Studie Eligibility Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources.
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.
Extension(Reference(Group | EvidenceVariable)) Extension URLhttps://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 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 |
| Akronym | S C | 0..1 | Extension(string) | There are no (further) constraints on this element Element idResearchStudy.extension:Akronym Short descriptionMII EX Studie Akronym Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources.
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.
Extension(string) Extension URLhttps://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 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 |
| Rekrutierung | S C | 0..1 | Extension(Complex) | There are no (further) constraints on this element Element idResearchStudy.extension:Rekrutierung Short descriptionMII EX Studie Rekrutierung Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources.
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.
Extension(Complex) Extension URLhttps://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 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 |
| Finanzierung | S C | 0..* | Extension(string) | There are no (further) constraints on this element Element idResearchStudy.extension:Finanzierung Short descriptionMII EX Studie Finanzierung Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources.
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.
Extension(string) Extension URLhttps://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 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 |
| modifierExtension | ?! C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.modifierExtension Short descriptionExtensions that cannot be ignored Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
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.
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.
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 |
| identifier | S Σ | 0..* | Identifier | Element idResearchStudy.identifier Short descriptionBusiness Identifier for study DefinitionIdentifiers assigned to this research study by the sponsor or other systems.
Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Identifier SlicingUnordered, Open, by system(Value) Slice für Identifikator eines Studienregisters bzw. studiendurchführenden Organisation anhand von `system` Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs
- w5: FiveWs.identifier
- BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
- rim: .identifier
|
| (All Slices) | | | | The requirements in this element apply to all slices |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.identifier.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.identifier.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
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.
Extension SlicingUnordered, 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 |
| use | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchStudy.identifier.use Short descriptionusual | official | temp | secondary | old (If known) DefinitionThe purpose of this identifier.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
code BindingIdentifies the purpose for this identifier, if known .
IdentifierUse (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: N/A
- rim: Role.code or implied by context
|
| type | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.identifier.type Short descriptionDescription of identifier DefinitionA coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Allows users to make use of identifiers when the identifier system is not known.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
CodeableConcept BindingA coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Identifier Type Codes (extensible) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.5
- rim: Role.code or implied by context
|
| system | S Σ | 0..1 | uri | There are no (further) constraints on this element Element idResearchStudy.identifier.system Short descriptionThe namespace for the identifier value DefinitionEstablishes the namespace for the value - that is, a URL that describes a set values that are unique.
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
Identifier.system is always case sensitive.
uri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Examples
Generalhttp://www.acme.com/identifiers/patient Mappings- v2: CX.4 / EI-2-4
- rim: II.root or Role.id.root
- servd: ./IdentifierType
|
| value | S Σ | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.identifier.value Short descriptionThe value that is unique DefinitionThe portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Examples
General123456 Mappings- v2: CX.1 / EI.1
- rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
- servd: ./Value
|
| period | Σ | 0..1 | Period | There are no (further) constraints on this element Element idResearchStudy.identifier.period Short descriptionTime period when id is/was valid for use DefinitionTime period during which identifier is/was valid for use.
Period Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.7 + CX.8
- rim: Role.effectiveTime or implied by context
- servd: ./StartDate and ./EndDate
|
| assigner | Σ | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element idResearchStudy.identifier.assigner Short descriptionOrganization that issued id (may be just text) DefinitionOrganization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
Reference(Organization) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.4 / (CX.4,CX.9,CX.10)
- rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
- servd: ./IdentifierIssuingAuthority
|
| NCT | S Σ | 0..1 | Identifier | There are no (further) constraints on this element Element idResearchStudy.identifier:NCT Short descriptionBusiness Identifier for study DefinitionIdentifiers assigned to this research study by the sponsor or other systems.
Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Identifier Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs
- w5: FiveWs.identifier
- BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
- rim: .identifier
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.identifier:NCT.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.identifier:NCT.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
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.
Extension SlicingUnordered, 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 |
| use | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchStudy.identifier:NCT.use Short descriptionusual | official | temp | secondary | old (If known) DefinitionThe purpose of this identifier.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
code BindingIdentifies the purpose for this identifier, if known .
IdentifierUse (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: N/A
- rim: Role.code or implied by context
|
| type | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.identifier:NCT.type Short descriptionDescription of identifier DefinitionA coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Allows users to make use of identifiers when the identifier system is not known.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
CodeableConcept BindingA coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Identifier Type Codes (extensible) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.5
- rim: Role.code or implied by context
|
| system | S Σ | 1..1 | uriPattern | Element idResearchStudy.identifier:NCT.system Short descriptionThe namespace for the identifier value DefinitionEstablishes the namespace for the value - that is, a URL that describes a set values that are unique.
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
Identifier.system is always case sensitive.
uri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Patternhttps://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct Examples
Generalhttp://www.acme.com/identifiers/patient Mappings- v2: CX.4 / EI-2-4
- rim: II.root or Role.id.root
- servd: ./IdentifierType
|
| value | S Σ | 1..1 | string | There are no (further) constraints on this element Element idResearchStudy.identifier:NCT.value Short descriptionThe value that is unique DefinitionThe portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Examples
General123456 Mappings- v2: CX.1 / EI.1
- rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
- servd: ./Value
|
| period | Σ | 0..1 | Period | There are no (further) constraints on this element Element idResearchStudy.identifier:NCT.period Short descriptionTime period when id is/was valid for use DefinitionTime period during which identifier is/was valid for use.
Period Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.7 + CX.8
- rim: Role.effectiveTime or implied by context
- servd: ./StartDate and ./EndDate
|
| assigner | Σ | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element idResearchStudy.identifier:NCT.assigner Short descriptionOrganization that issued id (may be just text) DefinitionOrganization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
Reference(Organization) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.4 / (CX.4,CX.9,CX.10)
- rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
- servd: ./IdentifierIssuingAuthority
|
| DRKS | S Σ | 0..1 | Identifier | There are no (further) constraints on this element Element idResearchStudy.identifier:DRKS Short descriptionBusiness Identifier for study DefinitionIdentifiers assigned to this research study by the sponsor or other systems.
Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Identifier Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs
- w5: FiveWs.identifier
- BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
- rim: .identifier
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.identifier:DRKS.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.identifier:DRKS.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
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.
Extension SlicingUnordered, 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 |
| use | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchStudy.identifier:DRKS.use Short descriptionusual | official | temp | secondary | old (If known) DefinitionThe purpose of this identifier.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
code BindingIdentifies the purpose for this identifier, if known .
IdentifierUse (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: N/A
- rim: Role.code or implied by context
|
| type | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.identifier:DRKS.type Short descriptionDescription of identifier DefinitionA coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Allows users to make use of identifiers when the identifier system is not known.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
CodeableConcept BindingA coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Identifier Type Codes (extensible) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.5
- rim: Role.code or implied by context
|
| system | S Σ | 1..1 | uriPattern | Element idResearchStudy.identifier:DRKS.system Short descriptionThe namespace for the identifier value DefinitionEstablishes the namespace for the value - that is, a URL that describes a set values that are unique.
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
Identifier.system is always case sensitive.
uri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Patternhttps://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks Examples
Generalhttp://www.acme.com/identifiers/patient Mappings- v2: CX.4 / EI-2-4
- rim: II.root or Role.id.root
- servd: ./IdentifierType
|
| value | S Σ | 1..1 | string | There are no (further) constraints on this element Element idResearchStudy.identifier:DRKS.value Short descriptionThe value that is unique DefinitionThe portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Examples
General123456 Mappings- v2: CX.1 / EI.1
- rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
- servd: ./Value
|
| period | Σ | 0..1 | Period | There are no (further) constraints on this element Element idResearchStudy.identifier:DRKS.period Short descriptionTime period when id is/was valid for use DefinitionTime period during which identifier is/was valid for use.
Period Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.7 + CX.8
- rim: Role.effectiveTime or implied by context
- servd: ./StartDate and ./EndDate
|
| assigner | Σ | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element idResearchStudy.identifier:DRKS.assigner Short descriptionOrganization that issued id (may be just text) DefinitionOrganization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
Reference(Organization) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.4 / (CX.4,CX.9,CX.10)
- rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
- servd: ./IdentifierIssuingAuthority
|
| EudraCT | S Σ | 0..1 | Identifier | There are no (further) constraints on this element Element idResearchStudy.identifier:EudraCT Short descriptionBusiness Identifier for study DefinitionIdentifiers assigned to this research study by the sponsor or other systems.
Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Identifier Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs
- w5: FiveWs.identifier
- BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
- rim: .identifier
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.identifier:EudraCT.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.identifier:EudraCT.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
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.
Extension SlicingUnordered, 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 |
| use | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchStudy.identifier:EudraCT.use Short descriptionusual | official | temp | secondary | old (If known) DefinitionThe purpose of this identifier.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
code BindingIdentifies the purpose for this identifier, if known .
IdentifierUse (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: N/A
- rim: Role.code or implied by context
|
| type | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.identifier:EudraCT.type Short descriptionDescription of identifier DefinitionA coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Allows users to make use of identifiers when the identifier system is not known.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
CodeableConcept BindingA coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Identifier Type Codes (extensible) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.5
- rim: Role.code or implied by context
|
| system | S Σ | 1..1 | uriPattern | Element idResearchStudy.identifier:EudraCT.system Short descriptionThe namespace for the identifier value DefinitionEstablishes the namespace for the value - that is, a URL that describes a set values that are unique.
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
Identifier.system is always case sensitive.
uri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Patternhttps://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract Examples
Generalhttp://www.acme.com/identifiers/patient Mappings- v2: CX.4 / EI-2-4
- rim: II.root or Role.id.root
- servd: ./IdentifierType
|
| value | S Σ | 1..1 | string | There are no (further) constraints on this element Element idResearchStudy.identifier:EudraCT.value Short descriptionThe value that is unique DefinitionThe portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Examples
General123456 Mappings- v2: CX.1 / EI.1
- rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
- servd: ./Value
|
| period | Σ | 0..1 | Period | There are no (further) constraints on this element Element idResearchStudy.identifier:EudraCT.period Short descriptionTime period when id is/was valid for use DefinitionTime period during which identifier is/was valid for use.
Period Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.7 + CX.8
- rim: Role.effectiveTime or implied by context
- servd: ./StartDate and ./EndDate
|
| assigner | Σ | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element idResearchStudy.identifier:EudraCT.assigner Short descriptionOrganization that issued id (may be just text) DefinitionOrganization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
Reference(Organization) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.4 / (CX.4,CX.9,CX.10)
- rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
- servd: ./IdentifierIssuingAuthority
|
| title | S Σ | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.title Short descriptionName for this study DefinitionA short, descriptive user-friendly label for the study.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Brief Title
- BRIDG5.1: No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
|
| protocol | Σ | 0..* | Reference(PlanDefinition) | There are no (further) constraints on this element Element idResearchStudy.protocol Short descriptionSteps followed in executing study DefinitionThe set of steps expected to be performed as part of the execution of the study.
Reference(PlanDefinition) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Interventions; Arm/Intervention Cross-Reference
- BRIDG5.1: StudyProtocolDocumentVersionPublicTitle.name
- rim: .outboundRelationship[typeCode=DEFN].target
|
| partOf | S Σ | 0..* | Reference(ResearchStudy) | There are no (further) constraints on this element Element idResearchStudy.partOf Short descriptionPart of larger study Alternate namescontainer DefinitionA larger research study of which this particular study is a component or step.
Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
Reference(ResearchStudy) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: CompanionStudyRelationship
- rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
|
| status | S Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element idResearchStudy.status Short descriptionactive | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn DefinitionThe current state of the study.
code BindingCodes that convey the current status of the research study.
ResearchStudyStatus (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- w5: FiveWs.status
- BRIDG5.1: StudyOverallStatus.code
- rim: .status
|
| primaryPurposeType | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.primaryPurposeType Short descriptiontreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility DefinitionThe type of study based upon the intent of the study's activities. A classification of the intent of the study.
CodeableConcept BindingCodes for the main intent of the study.
ResearchStudyPrimaryPurposeType (extensible) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: StudyProtocolVersion.primaryPurposeTypeCode
|
| phase | Σ | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.phase Short descriptionn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 DefinitionThe stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
CodeableConcept BindingCodes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
ResearchStudyPhase (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Study Phase
- BRIDG5.1: StudyProtocolVersion.phaseCode
|
| category | S Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.category Short descriptionClassifications for the study DefinitionCodes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
CodeableConcept BindingCodes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
(unbound) (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
- BRIDG5.1: InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
|
| focus | S Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.focus Short descriptionDrugs, devices, etc. under study DefinitionThe medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
CodeableConcept BindingCodes for medications, devices and other interventions.
(unbound) (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Focus of Study
- w5: FiveWs.what[x]
- BRIDG5.1: InterventionalStudyProtocol.interventionTypeCode
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.focus.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.focus.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
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.
Extension SlicingUnordered, 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 |
| coding | Σ | 0..* | Coding | There are no (further) constraints on this element Element idResearchStudy.focus.coding Short descriptionCode defined by a terminology system DefinitionA reference to a code defined by a terminology system.
Allows for alternative encodings within a code system, and translations to other code systems.
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Coding Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: C*E.1-8, C*E.10-22
- rim: union(., ./translation)
- orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
|
| text | S Σ | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.focus.text Short descriptionPlain text representation of the concept DefinitionA human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
Very often the text is the same as a displayName of one of the codings.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: C*E.9. But note many systems use C*E.2 for this
- rim: ./originalText[mediaType/code="text/plain"]/data
- orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
|
| condition | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.condition Short descriptionCondition being studied DefinitionThe condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.
CodeableConcept BindingIdentification of the condition or diagnosis.
Condition/Problem/DiagnosisCodes (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Conditions
- w5: FiveWs.what[x]
- BRIDG5.1: StudyCondition.code
|
| contact | Σ | 0..* | ContactDetail | There are no (further) constraints on this element Element idResearchStudy.contact Short descriptionContact details for the study DefinitionContact details to assist a user in learning more about or engaging with the study.
ContactDetail Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
- BRIDG5.1: PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
|
| relatedArtifact | | 0..* | RelatedArtifact | There are no (further) constraints on this element Element idResearchStudy.relatedArtifact Short descriptionReferences and dependencies DefinitionCitations, references and other related documents.
RelatedArtifact Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Citations, Links, Available Study Data/Documents
- BRIDG5.1: StudyProtocolDocument, StudyProtocolDocumentVersion
|
| keyword | S Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.keyword Short descriptionUsed to search for the study DefinitionKey terms to aid in searching for or filtering the study.
CodeableConcept BindingWords associated with the study that may be useful in discovery.
(unbound) (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Keywords
- BRIDG5.1: DocumentVersion.keywordCode; DocumentVersion.keywordText
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.keyword.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.keyword.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
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.
Extension SlicingUnordered, 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 |
| coding | Σ | 0..* | Coding | There are no (further) constraints on this element Element idResearchStudy.keyword.coding Short descriptionCode defined by a terminology system DefinitionA reference to a code defined by a terminology system.
Allows for alternative encodings within a code system, and translations to other code systems.
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Coding Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: C*E.1-8, C*E.10-22
- rim: union(., ./translation)
- orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
|
| text | S Σ | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.keyword.text Short descriptionPlain text representation of the concept DefinitionA human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
Very often the text is the same as a displayName of one of the codings.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: C*E.9. But note many systems use C*E.2 for this
- rim: ./originalText[mediaType/code="text/plain"]/data
- orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
|
| location | Σ | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.location Short descriptionGeographic region(s) for study DefinitionIndicates a country, state or other region where the study is taking place.
CodeableConcept BindingCountries and regions within which this artifact is targeted for use.
Jurisdiction ValueSet (extensible) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: StudyProtocolVersion.participatingLocationCode
|
| description | | 0..1 | markdown | There are no (further) constraints on this element Element idResearchStudy.description Short descriptionWhat this is study doing DefinitionA full description of how the study is being conducted.
markdown Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Detailed Description
- BRIDG5.1: StudyProtocolDocumentVersion.publicDescription
|
| enrollment | Σ | 0..* | Reference(Group) | There are no (further) constraints on this element Element idResearchStudy.enrollment Short descriptionInclusion & exclusion criteria Alternate namespatient DefinitionReference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".
The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
Reference(Group) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
- w5: FiveWs.subject[x]
- BRIDG5.1: InterventionalStudyProtocol.interventionGroupQuantity
- rim: .participation[typeCode=SBJ].role
- w5: FiveWs.subject
|
| period | Σ | 0..1 | Period | There are no (further) constraints on this element Element idResearchStudy.period Short descriptionWhen the study began and ended Alternate namestiming DefinitionIdentifies the start date and the expected (or actual, depending on status) end date for the study.
Period Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Study Start Date (start); Study Completion Date (end)
- w5: FiveWs.done[x]
- BRIDG5.1: ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
- rim: .effectiveTime
|
| principalInvestigator | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | There are no (further) constraints on this element Element idResearchStudy.principalInvestigator Short descriptionResearcher who oversees multiple aspects of the study DefinitionA researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.
Reference(Practitioner | PractitionerRole) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Principal Investigator
- w5: FiveWs.actor
- BRIDG5.1: StudyInvestigator
|
| site | Σ | 0..* | Reference(Location) | There are no (further) constraints on this element Element idResearchStudy.site Short descriptionFacility where study activities are conducted DefinitionA facility in which study activities are conducted.
Reference(Location) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Facility
- w5: FiveWs.where[x]
- BRIDG5.1: PlannedStudySite; StudySite
|
| reasonStopped | Σ | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.reasonStopped Short descriptionaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design DefinitionA description and/or code explaining the premature termination of the study.
CodeableConcept BindingCodes for why the study ended prematurely.
ResearchStudyReasonStopped (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Why Study Stopped
- w5: FiveWs.why[x]
- BRIDG5.1: StudyOverallStatus.studyStoppedReasonCode
|
| note | | 0..* | Annotation | There are no (further) constraints on this element Element idResearchStudy.note Short descriptionComments made about the study DefinitionComments made about the study by the performer, subject or other participants.
Annotation Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: No BRIDG mapping
- rim: .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
|
| arm | S | 0..* | BackboneElement | There are no (further) constraints on this element Element idResearchStudy.arm Short descriptionDefined path through the study for a subject DefinitionDescribes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.
BackboneElement Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Arms
- BRIDG5.1: Arm
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.arm.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.arm.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
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.
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 |
| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.arm.modifierExtension Short descriptionExtensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay 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).
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.
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.
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 |
| name | S | 1..1 | string | There are no (further) constraints on this element Element idResearchStudy.arm.name Short descriptionLabel for study arm DefinitionUnique, human-readable label for this arm of the study.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Arm Label
- BRIDG5.1: Arm.name
|
| type | | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.arm.type Short descriptionCategorization of study arm DefinitionCategorization of study arm, e.g. experimental, active comparator, placebo comparater.
CodeableConcept Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Arm Type
- BRIDG5.1: Arm.typeCode
|
| description | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.arm.description Short descriptionShort explanation of study path DefinitionA succinct description of the path through the study that would be followed by a subject adhering to this arm.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Arm Description
- BRIDG5.1: Arm.description
|
| objective | | 0..* | BackboneElement | There are no (further) constraints on this element Element idResearchStudy.objective Short descriptionA goal for the study DefinitionA goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.
BackboneElement Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.objective.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.objective.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
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.
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 |
| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.objective.modifierExtension Short descriptionExtensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay 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).
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.
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.
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 |
| name | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.objective.name Short descriptionLabel for the objective DefinitionUnique, human-readable label for this objective of the study.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: No BRIDG mapping (BRIDG has a description, but not a name)
|
| type | | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.objective.type Short descriptionprimary | secondary | exploratory DefinitionThe kind of study objective.
CodeableConcept BindingCodes for the kind of study objective.
ResearchStudyObjectiveType (preferred) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: StudyObjective.typeCode
|