MII IG Kerndatensatz-Modul Molekulares Tumorboard
2027.0.0-ballot.1 - Germany

This page is part of the MII Implementation Guide Molecular Tumor Board (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: MII PR MTB Studie

Official URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie Version: 2027.0.0-ballot.1
Active as of 2026-09-15 Computable Name: MII_PR_MTB_Studie

Onkologische Studie

Content

This profile describes, as part of the study inclusion recommendation, the study into which inclusion is recommended.

The present profile mainly defines three identifier systems that are frequently used in the context of studies at the Molekulares Tumorboard (molecular tumor board):

The use of the study profile is optional - this module formally ends with the study inclusion recommendation.

In future expansion stages, the local study population of a study can, for example, be aggregated via Group, and the actual study participation can be used as an evaluation parameter. Furthermore, it can be defined in the future to what extent a study participation can be captured separately in the follow-up.

Content

Mapping dataset to FHIR

TODO: correct FHIR LM mappings

Search parameters

The following search parameters are relevant for this module, including in combination:

  1. The search parameter "_id" MUST be supported:

    Examples:

    GET [base]/ResearchStudy?_id=12345

    Usage notes: Further information on searching by "_id" can be found in the FHIR base specification - section "Parameters for all resources".

  2. The search parameter "_profile" MUST be supported:

    Examples:

    GET [base]/ResearchStudy?_profile=https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie

    Usage notes: Further information on searching by "_id" can be found in the FHIR base specification - section "Parameters for all resources".

  3. The search parameter "identifier" MUST be supported:

    Examples

    GET [base]/ResearchStudy?identifier=DRKS00031294

    Usage notes: Further information on searching by "identifier" can be found in the FHIR base specification - section "Token Search".

  4. The search parameter "title" MUST be supported:

    Examples

    GET [base]/ResearchStudy?title=Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue

    Usage notes: Further information on searching by "title" can be found in the FHIR base specification - section "String Search".

  5. The search parameter "status" MUST be supported:

    Examples

    GET [base]/ResearchStudy?status=active

    Usage notes: Further information on searching by "status" can be found in the FHIR base specification - section "Token Search".

  6. The search parameter "partOf" MUST be supported:

    Examples

    GET [base]/ResearchStudy?partOf=ResearchStudy/researchstudy-test

    Usage notes: Further information on searching by "partOf" can be found in the FHIR base specification - section "Reference Search".

  7. The search parameter "category" MUST be supported:

    Examples

    GET [base]/ResearchStudy?category=interventional

    Usage notes: Further information on searching by "category" can be found in the FHIR base specification - section "Token Search".

  8. The search parameter "armName" MUST be supported:

    Examples

    GET [base]/ResearchStudy?armName=frontale anodale tDCS (verum condition)

    Usage notes: Further information on searching by "arm.name" can be found in the FHIR base specification - section "String Search".

  9. The search parameter "category" MUST be supported:

    Examples

    GET [base]/ResearchStudy?category=Long-COVID bedingter Fatigue

    Usage notes: Further information on searching by "extension:Studienfokus" can be found in the FHIR base specification - section "String Search".

  10. The search parameter "keyword" MUST be supported:

    Examples

    GET [base]/ResearchStudy?keyword=COVID

    Usage notes: Further information on searching by "extension:Schlagwort" can be found in the FHIR base specification - section "String Search".

  11. The search parameter "label" MUST be supported:

    Examples

    GET [base]/ResearchStudy?label=Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue

    Usage notes: Further information on searching by "extension:Label" can be found in the FHIR base specification - section "String Search".

  12. The search parameter "studienregister" MUST be supported:

    Examples

    GET [base]/ResearchStudy?studienregister=Library/example

    Usage notes: Further information on searching by "extension:Studienregister" can be found in the FHIR base specification - section "Reference Search".

  13. The search parameter "rekrutierungsstand-datum" MUST be supported:

    Examples

    GET [base]/ResearchStudy?rekrutierungsstand-datum=2023-02-17

    Usage notes: Further information on searching by "extension:Rekrutierung.extension:rekrutierungsstand-datum" can be found in the FHIR base specification - section "Date Search".

  14. The search parameter "rekrutierungsstand-genauigkeit" MUST be supported:

    Examples

    GET [base]/ResearchStudy?rekrutierungsstand-genauigkeit=good

    Usage notes: Further information on searching by "extension:Rekrutierung.extension:rekrutierungsstand-genauigkeit" can be found in the [FHIR base specification - section "String Search"].(http://hl7.org/fhir/R4/search.html#string).

  15. The search parameter "rekrutierungsstand-rekrutierungsstand" MUST be supported:

    Examples

    GET [base]/ResearchStudy?rekrutierungsstand=35

    Usage notes: Further information on searching by "extension:Rekrutierung.extension:rekrutierungsstand" can be found in the FHIR base specification - section "Number Search".

  16. The search parameter "rekrutierungsstand-rekrutierungsziel" MUST be supported:

    Examples

    GET [base]/ResearchStudy?rekrutierungsziel=40

    Usage notes: Further information on searching by "extension:Rekrutierung.extension:rekrutierungsziel" can be found in the FHIR base specification - section "Number Search".

  17. The search parameter "rekrutierungsstand-rekrutierungsstart" MUST be supported:

    Examples

    GET [base]/ResearchStudy?rekrutierungsstart=2023-01-12

    Usage notes: Further information on searching by "extension:Rekrutierung.extension:rekrutierungsstart" can be found in the FHIR base specification - section "Date Search".

Examples

Example: Recommended study for Kim Musterperson dated 2023-03-28 (see Scenarios)

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots, and their representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* MII_PR_Studie_Studie Investigation to increase healthcare-related patient-independent knowledge
... meta SΣ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension S 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:Label S 0..* (Complex) MII EX Studie Backport Label
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
.... extension:AssociatedParty S 0..* (Complex) MII EX Studie Backport AssociatedParty
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
.... extension:Ethikvotum S 0..* (Complex) MII EX Studie Ethikvotum
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum
.... extension:Studienregister S 0..* Reference(Library) MII EX Studie Studienregister
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister
.... extension:Eligibility S 0..1 Reference(Group | EvidenceVariable) MII EX Studie Eligibility
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility
.... extension:Akronym S 0..1 string MII EX Studie Akronym
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym
.... extension:Rekrutierung S 0..1 (Complex) MII EX Studie Rekrutierung
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung
.... extension:Finanzierung S 0..* string MII EX Studie Finanzierung
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung
... Slices for identifier SΣ 0..* Identifier Business Identifier for study.
Slice: Unordered, Open by value:system
.... identifier:All Slices Content/Rules for all slices
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system SΣ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣ 0..1 string The value that is unique
Example General: 123456
.... identifier:NCT SΣ 0..1 Identifier Business Identifier for study.
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system SΣ 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct
..... value SΣ 1..1 string The value that is unique
Example General: 123456
.... identifier:DRKS SΣ 0..1 Identifier Business Identifier for study.
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system SΣ 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks
..... value SΣ 1..1 string The value that is unique
Example General: 123456
.... identifier:EudraCT SΣ 0..1 Identifier Business Identifier for study.
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system SΣ 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract
..... value SΣ 1..1 string The value that is unique
Example General: 123456
... title SΣ 0..1 string Name for this study.
... partOf SΣ 0..* Reference(ResearchStudy) Part of larger study.
... status ?!SΣ 1..1 code active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
... category SΣ 0..* CodeableConcept Classifications for the study.
Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
... focus SΣ 0..* CodeableConcept Drugs, devices, etc. under study
Binding Description: (example): Codes for medications, devices and other interventions.
.... text SΣ 0..1 string Plain text representation of the concept
... keyword SΣ 0..* CodeableConcept Used to search for the study.
Binding Description: (example): Words associated with the study that may be useful in discovery.
.... text SΣ 0..1 string Plain text representation of the concept
... arm S 0..* BackboneElement Defined path through the study for a subject.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name S 1..1 string Label for study arm

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.identifier.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:NCT.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:DRKS.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:EudraCT.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.status Base required ResearchStudyStatus 📍4.0.1 FHIR Std.
ResearchStudy.category Base example Not State Unknown
ResearchStudy.focus Base example Not State Unknown
ResearchStudy.keyword Base example Not State Unknown

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchStudy If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchStudy 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 error ResearchStudy 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 error ResearchStudy If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchStudy A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* MII_PR_Studie_Studie Investigation to increase healthcare-related patient-independent knowledge
... meta S 0..1 Meta Metadata about the resource
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... Slices for identifier 0..* Identifier Business Identifier for study.
Slice: Unordered, Open by value:system
.... identifier:NCT 0..1 Identifier Business Identifier for study.
..... system 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct
..... value 1..1 string The value that is unique
.... identifier:DRKS 0..1 Identifier Business Identifier for study.
..... system 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks
..... value 1..1 string The value that is unique
.... identifier:EudraCT 0..1 Identifier Business Identifier for study.
..... system 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract
..... value 1..1 string The value that is unique

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* MII_PR_Studie_Studie Investigation to increase healthcare-related patient-independent knowledge
... id Σ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension S 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:Label S 0..* (Complex) MII EX Studie Backport Label
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
.... extension:AssociatedParty S 0..* (Complex) MII EX Studie Backport AssociatedParty
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
.... extension:Ethikvotum S 0..* (Complex) MII EX Studie Ethikvotum
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum
.... extension:Studienregister S 0..* Reference(Library) MII EX Studie Studienregister
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister
.... extension:Eligibility S 0..1 Reference(Group | EvidenceVariable) MII EX Studie Eligibility
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility
.... extension:Akronym S 0..1 string MII EX Studie Akronym
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym
.... extension:Rekrutierung S 0..1 (Complex) MII EX Studie Rekrutierung
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung
.... extension:Finanzierung S 0..* string MII EX Studie Finanzierung
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... Slices for identifier SΣ 0..* Identifier Business Identifier for study.
Slice: Unordered, Open by value:system
.... identifier:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system SΣ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣ 0..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:NCT SΣ 0..1 Identifier Business Identifier for study.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system SΣ 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct
..... value SΣ 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:DRKS SΣ 0..1 Identifier Business Identifier for study.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system SΣ 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks
..... value SΣ 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:EudraCT SΣ 0..1 Identifier Business Identifier for study.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system SΣ 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract
..... value SΣ 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... title SΣ 0..1 string Name for this study.
... protocol Σ 0..* Reference(PlanDefinition) Steps followed in executing study
... partOf SΣ 0..* Reference(ResearchStudy) Part of larger study.
... status ?!SΣ 1..1 code active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
... primaryPurposeType Σ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
... phase Σ 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
... category SΣ 0..* CodeableConcept Classifications for the study.
Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
... focus SΣ 0..* CodeableConcept Drugs, devices, etc. under study
Binding Description: (example): Codes for medications, devices and other interventions.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
.... text SΣ 0..1 string Plain text representation of the concept
... condition Σ 0..* CodeableConcept Condition being studied
Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
... contact Σ 0..* ContactDetail Contact details for the study
... relatedArtifact 0..* RelatedArtifact References and dependencies
... keyword SΣ 0..* CodeableConcept Used to search for the study.
Binding Description: (example): Words associated with the study that may be useful in discovery.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
.... text SΣ 0..1 string Plain text representation of the concept
... location Σ 0..* CodeableConcept Geographic region(s) for study
Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
... description 0..1 markdown What this is study doing
... enrollment Σ 0..* Reference(Group) Inclusion & exclusion criteria
... period Σ 0..1 Period When the study began and ended
... sponsor Σ 0..1 Reference(Organization) Organization that initiates and is legally responsible for the study
... principalInvestigator Σ 0..1 Reference(Practitioner | PractitionerRole) Researcher who oversees multiple aspects of the study
... site Σ 0..* Reference(Location) Facility where study activities are conducted
... reasonStopped Σ 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
... note 0..* Annotation Comments made about the study
... arm S 0..* BackboneElement Defined path through the study for a subject.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name S 1..1 string Label for study arm
.... type 0..1 CodeableConcept Categorization of study arm
.... description 0..1 string Short explanation of study path
... objective 0..* BackboneElement A goal for the study
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 0..1 string Label for the objective
.... type 0..1 CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
ResearchStudy.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
ResearchStudy.language Base preferred Common Languages 📍4.0.1 FHIR Std.
ResearchStudy.identifier.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchStudy.identifier:NCT.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:NCT.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchStudy.identifier:DRKS.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:DRKS.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchStudy.identifier:EudraCT.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:EudraCT.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchStudy.status Base required ResearchStudyStatus 📍4.0.1 FHIR Std.
ResearchStudy.primaryPurposeType Base extensible ResearchStudyPrimaryPurposeType 📍4.0.1 FHIR Std.
ResearchStudy.phase Base example ResearchStudyPhase 📍4.0.1 FHIR Std.
ResearchStudy.category Base example Not State Unknown
ResearchStudy.focus Base example Not State Unknown
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.keyword Base example Not State Unknown
ResearchStudy.location Base extensible Jurisdiction 📍4.0.1 FHIR Std.
ResearchStudy.reasonStopped Base example ResearchStudyReasonStopped 📍4.0.1 FHIR Std.
ResearchStudy.objective.​type Base preferred ResearchStudyObjectiveType 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchStudy If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchStudy 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 error ResearchStudy 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 error ResearchStudy If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchStudy A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Mandatory: 0 element(6 nested mandatory elements)
Must-Support: 2 elements

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of ResearchStudy.identifier

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* MII_PR_Studie_Studie Investigation to increase healthcare-related patient-independent knowledge
... meta SΣ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension S 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:Label S 0..* (Complex) MII EX Studie Backport Label
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
.... extension:AssociatedParty S 0..* (Complex) MII EX Studie Backport AssociatedParty
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
.... extension:Ethikvotum S 0..* (Complex) MII EX Studie Ethikvotum
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum
.... extension:Studienregister S 0..* Reference(Library) MII EX Studie Studienregister
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister
.... extension:Eligibility S 0..1 Reference(Group | EvidenceVariable) MII EX Studie Eligibility
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility
.... extension:Akronym S 0..1 string MII EX Studie Akronym
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym
.... extension:Rekrutierung S 0..1 (Complex) MII EX Studie Rekrutierung
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung
.... extension:Finanzierung S 0..* string MII EX Studie Finanzierung
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung
... Slices for identifier SΣ 0..* Identifier Business Identifier for study.
Slice: Unordered, Open by value:system
.... identifier:All Slices Content/Rules for all slices
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system SΣ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣ 0..1 string The value that is unique
Example General: 123456
.... identifier:NCT SΣ 0..1 Identifier Business Identifier for study.
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system SΣ 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct
..... value SΣ 1..1 string The value that is unique
Example General: 123456
.... identifier:DRKS SΣ 0..1 Identifier Business Identifier for study.
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system SΣ 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks
..... value SΣ 1..1 string The value that is unique
Example General: 123456
.... identifier:EudraCT SΣ 0..1 Identifier Business Identifier for study.
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system SΣ 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract
..... value SΣ 1..1 string The value that is unique
Example General: 123456
... title SΣ 0..1 string Name for this study.
... partOf SΣ 0..* Reference(ResearchStudy) Part of larger study.
... status ?!SΣ 1..1 code active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
... category SΣ 0..* CodeableConcept Classifications for the study.
Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
... focus SΣ 0..* CodeableConcept Drugs, devices, etc. under study
Binding Description: (example): Codes for medications, devices and other interventions.
.... text SΣ 0..1 string Plain text representation of the concept
... keyword SΣ 0..* CodeableConcept Used to search for the study.
Binding Description: (example): Words associated with the study that may be useful in discovery.
.... text SΣ 0..1 string Plain text representation of the concept
... arm S 0..* BackboneElement Defined path through the study for a subject.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name S 1..1 string Label for study arm

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.identifier.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:NCT.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:DRKS.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:EudraCT.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.status Base required ResearchStudyStatus 📍4.0.1 FHIR Std.
ResearchStudy.category Base example Not State Unknown
ResearchStudy.focus Base example Not State Unknown
ResearchStudy.keyword Base example Not State Unknown

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchStudy If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchStudy 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 error ResearchStudy 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 error ResearchStudy If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchStudy A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* MII_PR_Studie_Studie Investigation to increase healthcare-related patient-independent knowledge
... meta S 0..1 Meta Metadata about the resource
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... Slices for identifier 0..* Identifier Business Identifier for study.
Slice: Unordered, Open by value:system
.... identifier:NCT 0..1 Identifier Business Identifier for study.
..... system 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct
..... value 1..1 string The value that is unique
.... identifier:DRKS 0..1 Identifier Business Identifier for study.
..... system 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks
..... value 1..1 string The value that is unique
.... identifier:EudraCT 0..1 Identifier Business Identifier for study.
..... system 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract
..... value 1..1 string The value that is unique

doco Documentation for this format

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* MII_PR_Studie_Studie Investigation to increase healthcare-related patient-independent knowledge
... id Σ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension S 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:Label S 0..* (Complex) MII EX Studie Backport Label
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
.... extension:AssociatedParty S 0..* (Complex) MII EX Studie Backport AssociatedParty
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
.... extension:Ethikvotum S 0..* (Complex) MII EX Studie Ethikvotum
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum
.... extension:Studienregister S 0..* Reference(Library) MII EX Studie Studienregister
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister
.... extension:Eligibility S 0..1 Reference(Group | EvidenceVariable) MII EX Studie Eligibility
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility
.... extension:Akronym S 0..1 string MII EX Studie Akronym
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym
.... extension:Rekrutierung S 0..1 (Complex) MII EX Studie Rekrutierung
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung
.... extension:Finanzierung S 0..* string MII EX Studie Finanzierung
URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... Slices for identifier SΣ 0..* Identifier Business Identifier for study.
Slice: Unordered, Open by value:system
.... identifier:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system SΣ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣ 0..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:NCT SΣ 0..1 Identifier Business Identifier for study.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system SΣ 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct
..... value SΣ 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:DRKS SΣ 0..1 Identifier Business Identifier for study.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system SΣ 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks
..... value SΣ 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:EudraCT SΣ 0..1 Identifier Business Identifier for study.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system SΣ 1..1 uri The namespace for the identifier value
Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract
..... value SΣ 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... title SΣ 0..1 string Name for this study.
... protocol Σ 0..* Reference(PlanDefinition) Steps followed in executing study
... partOf SΣ 0..* Reference(ResearchStudy) Part of larger study.
... status ?!SΣ 1..1 code active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
... primaryPurposeType Σ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
... phase Σ 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
... category SΣ 0..* CodeableConcept Classifications for the study.
Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
... focus SΣ 0..* CodeableConcept Drugs, devices, etc. under study
Binding Description: (example): Codes for medications, devices and other interventions.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
.... text SΣ 0..1 string Plain text representation of the concept
... condition Σ 0..* CodeableConcept Condition being studied
Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
... contact Σ 0..* ContactDetail Contact details for the study
... relatedArtifact 0..* RelatedArtifact References and dependencies
... keyword SΣ 0..* CodeableConcept Used to search for the study.
Binding Description: (example): Words associated with the study that may be useful in discovery.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
.... text SΣ 0..1 string Plain text representation of the concept
... location Σ 0..* CodeableConcept Geographic region(s) for study
Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
... description 0..1 markdown What this is study doing
... enrollment Σ 0..* Reference(Group) Inclusion & exclusion criteria
... period Σ 0..1 Period When the study began and ended
... sponsor Σ 0..1 Reference(Organization) Organization that initiates and is legally responsible for the study
... principalInvestigator Σ 0..1 Reference(Practitioner | PractitionerRole) Researcher who oversees multiple aspects of the study
... site Σ 0..* Reference(Location) Facility where study activities are conducted
... reasonStopped Σ 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
... note 0..* Annotation Comments made about the study
... arm S 0..* BackboneElement Defined path through the study for a subject.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name S 1..1 string Label for study arm
.... type 0..1 CodeableConcept Categorization of study arm
.... description 0..1 string Short explanation of study path
... objective 0..* BackboneElement A goal for the study
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 0..1 string Label for the objective
.... type 0..1 CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
ResearchStudy.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
ResearchStudy.language Base preferred Common Languages 📍4.0.1 FHIR Std.
ResearchStudy.identifier.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchStudy.identifier:NCT.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:NCT.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchStudy.identifier:DRKS.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:DRKS.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchStudy.identifier:EudraCT.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:EudraCT.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchStudy.status Base required ResearchStudyStatus 📍4.0.1 FHIR Std.
ResearchStudy.primaryPurposeType Base extensible ResearchStudyPrimaryPurposeType 📍4.0.1 FHIR Std.
ResearchStudy.phase Base example ResearchStudyPhase 📍4.0.1 FHIR Std.
ResearchStudy.category Base example Not State Unknown
ResearchStudy.focus Base example Not State Unknown
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.keyword Base example Not State Unknown
ResearchStudy.location Base extensible Jurisdiction 📍4.0.1 FHIR Std.
ResearchStudy.reasonStopped Base example ResearchStudyReasonStopped 📍4.0.1 FHIR Std.
ResearchStudy.objective.​type Base preferred ResearchStudyObjectiveType 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchStudy If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchStudy 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 error ResearchStudy 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 error ResearchStudy If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchStudy A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Mandatory: 0 element(6 nested mandatory elements)
Must-Support: 2 elements

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of ResearchStudy.identifier

 

Other representations of profile: CSV, Excel, Schematron