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. For a full list of available versions, see the Directory of published versions

Ressourcenprofil: MII PR MTB Studie

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

Onkologische Studie

Inhalt

Dieses Profil beschreibt als Teil der Studieneinschlussempfehlung die Studie, in die der Einschluss empfohlen wird.

Das vorliegende Profil definiert hauptsächlich drei Identifiersysteme, die im Rahmen von Studien am Molekularen Tumorboard häufig genutzt werden:

Die Verwendung des Studienprofils ist optional - dieses Modul endet formal mit der Studieneinschlussempfehlung.

In zukünftigen Ausbaustufen kann die lokale Studienpopulation einer Studie über bspw. über Group zusammenaggregiert und die tatsächliche Studienteilnahme als Auswertungsparameter genutzt werden. Weiterhin kann in Zukunft definiert werden, inwieweit eine Studienteilnahme im Follow-up getrennt erfasst werden kann.

Inhalt

Mapping Datensatz zu FHIR

TODO: FHIR LM Mappings korrigieren

Suchparameter

Folgende Suchparameter sind für diese Modul relevant, auch in Kombination:

  1. Der Suchparameter "_id" MUSS unterstützt werden:

    Beispiele:

    GET [base]/ResearchStudy?_id=12345

    Anwendungshinweise: Weitere Informationen zur Suche nach "_id" finden sich in der FHIR-Basisspezifikation - Abschnitt "Parameters for all resources".

  2. Der Suchparameter "_profile" MUSS unterstützt werden:

    Beispiele:

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

    Anwendungshinweise: Weitere Informationen zur Suche nach "_id" finden sich in der FHIR-Basisspezifikation - Abschnitt "Parameters for all resources".

  3. Der Suchparameter "identifier" MUSS unterstützt werden:

    Beispiele

    GET [base]/ResearchStudy?identifier=DRKS00031294

    Anwendungshinweise: Weitere Informationen zur Suche nach "identifier" finden sich in der FHIR-Basisspezifikation - Abschnitt "Token Search".

  4. Der Suchparameter "title" MUSS unterstützt werden:

    Beispiele

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

    Anwendungshinweise: Weitere Informationen zur Suche nach "title" finden sich in der FHIR-Basisspezifikation - Abschnitt "String Search".

  5. Der Suchparameter "status" MUSS unterstützt werden:

    Beispiele

    GET [base]/ResearchStudy?status=active

    Anwendungshinweise: Weitere Informationen zur Suche nach "status" finden sich in der FHIR-Basisspezifikation - Abschnitt "Token Search".

  6. Der Suchparameter "partOf" MUSS unterstützt werden:

    Beispiele

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

    Anwendungshinweise: Weitere Informationen zur Suche nach "partOf" finden sich in der FHIR-Basisspezifikation - Abschnitt "Reference Search".

  7. Der Suchparameter "category" MUSS unterstützt werden:

    Beispiele

    GET [base]/ResearchStudy?category=interventional

    Anwendungshinweise: Weitere Informationen zur Suche nach "category" finden sich in der FHIR-Basisspezifikation - Abschnitt "Token Search".

  8. Der Suchparameter "armName" MUSS unterstützt werden:

    Beispiele

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

    Anwendungshinweise: Weitere Informationen zur Suche nach "arm.name" finden sich in der FHIR-Basisspezifikation - Abschnitt "String Search".

  9. Der Suchparameter "category" MUSS unterstützt werden:

    Beispiele

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

    Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Studienfokus" finden sich in der FHIR-Basisspezifikation - Abschnitt "String Search".

  10. Der Suchparameter "keyword" MUSS unterstützt werden:

    Beispiele

    GET [base]/ResearchStudy?keyword=COVID

    Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Schlagwort" finden sich in der FHIR-Basisspezifikation - Abschnitt "String Search".

  11. Der Suchparameter "label" MUSS unterstützt werden:

    Beispiele

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

    Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Label" finden sich in der FHIR-Basisspezifikation - Abschnitt "String Search".

  12. Der Suchparameter "studienregister" MUSS unterstützt werden:

    Beispiele

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

    Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Studienregister" finden sich in der FHIR-Basisspezifikation - Abschnitt "Reference Search".

  13. Der Suchparameter "rekrutierungsstand-datum" MUSS unterstützt werden:

    Beispiele

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

    Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Rekrutierung.extension:rekrutierungsstand-datum" finden sich in der FHIR-Basisspezifikation - Abschnitt "Date Search".

  14. Der Suchparameter "rekrutierungsstand-genauigkeit" MUSS unterstützt werden:

    Beispiele

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

    Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Rekrutierung.extension:rekrutierungsstand-genauigkeit" finden sich in der [FHIR-Basisspezifikation - Abschnitt "String Search"].(http://hl7.org/fhir/R4/search.html#string).

  15. Der Suchparameter "rekrutierungsstand-rekrutierungsstand" MUSS unterstützt werden:

    Beispiele

    GET [base]/ResearchStudy?rekrutierungsstand=35

    Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Rekrutierung.extension:rekrutierungsstand" finden sich in der FHIR-Basisspezifikation - Abschnitt "Number Search".

  16. Der Suchparameter "rekrutierungsstand-rekrutierungsziel" MUSS unterstützt werden:

    Beispiele

    GET [base]/ResearchStudy?rekrutierungsziel=40

    Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Rekrutierung.extension:rekrutierungsziel" finden sich in der FHIR-Basisspezifikation - Abschnitt "Number Search".

  17. Der Suchparameter "rekrutierungsstand-rekrutierungsstart" MUSS unterstützt werden:

    Beispiele

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

    Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Rekrutierung.extension:rekrutierungsstart" finden sich in der FHIR-Basisspezifikation - Abschnitt "Date Search".

Beispiele

Beispiel: Empfohlene Studie für Kim Musterperson vom 28.03.2023 (siehe Szenarien)

Usages:

You can also check for usages in the FHIR IG Statistics

Formale Ansichten des Profilinhalts

Beschreibung von Profilen, Differentials, Snapshots und deren Repräsentationen.

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 Name für diese Studie.
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 Name für diese Studie.
..... 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 Name für diese Studie.
..... 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 Name für diese Studie.
..... 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 für diese Studie.
... partOf SΣ 0..* Reference(ResearchStudy) Teil einer größeren Studie.
... status ?!SΣ 1..1 code aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
... category SΣ 0..* CodeableConcept Klassifikationen für die Studie.
Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
... focus SΣ 0..* CodeableConcept Untersuchte Medikamente, Geräte usw.
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 Wird verwendet, um nach der Studie zu suchen.
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 Definierter Weg durch die Studie für ein Subjekt.
.... 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()

Diese Struktur ist abgeleitet von MII_PR_Studie_Studie

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 Name für diese Studie.
Slice: Unordered, Open by value:system
.... identifier:NCT 0..1 Identifier Name für diese Studie.
..... 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 Name für diese Studie.
..... 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 Name für diese Studie.
..... 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 Name für diese Studie.
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 Name für diese Studie.
..... 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 Name für diese Studie.
..... 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 Name für diese Studie.
..... 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 für diese Studie.
... protocol Σ 0..* Reference(PlanDefinition) Steps followed in executing study
... partOf SΣ 0..* Reference(ResearchStudy) Teil einer größeren Studie.
... status ?!SΣ 1..1 code aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen
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 Klassifikationen für die Studie.
Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
... focus SΣ 0..* CodeableConcept Untersuchte Medikamente, Geräte usw.
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 Wird verwendet, um nach der Studie zu suchen.
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 Definierter Weg durch die Studie für ein Subjekt.
.... 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()

Diese Struktur ist abgeleitet von MII_PR_Studie_Studie

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

Schlüsselelemente-Ansicht

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 Name für diese Studie.
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 Name für diese Studie.
..... 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 Name für diese Studie.
..... 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 Name für diese Studie.
..... 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 für diese Studie.
... partOf SΣ 0..* Reference(ResearchStudy) Teil einer größeren Studie.
... status ?!SΣ 1..1 code aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
... category SΣ 0..* CodeableConcept Klassifikationen für die Studie.
Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
... focus SΣ 0..* CodeableConcept Untersuchte Medikamente, Geräte usw.
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 Wird verwendet, um nach der Studie zu suchen.
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 Definierter Weg durch die Studie für ein Subjekt.
.... 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-Ansicht

Diese Struktur ist abgeleitet von MII_PR_Studie_Studie

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 Name für diese Studie.
Slice: Unordered, Open by value:system
.... identifier:NCT 0..1 Identifier Name für diese Studie.
..... 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 Name für diese Studie.
..... 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 Name für diese Studie.
..... 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-AnsichtView

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 Name für diese Studie.
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 Name für diese Studie.
..... 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 Name für diese Studie.
..... 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 Name für diese Studie.
..... 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 für diese Studie.
... protocol Σ 0..* Reference(PlanDefinition) Steps followed in executing study
... partOf SΣ 0..* Reference(ResearchStudy) Teil einer größeren Studie.
... status ?!SΣ 1..1 code aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen
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 Klassifikationen für die Studie.
Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
... focus SΣ 0..* CodeableConcept Untersuchte Medikamente, Geräte usw.
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 Wird verwendet, um nach der Studie zu suchen.
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 Definierter Weg durch die Studie für ein Subjekt.
.... 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()

Diese Struktur ist abgeleitet von MII_PR_Studie_Studie

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

 

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