Kerndatensatz Senologie - Local Development build (v0.9.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Resource Profile: BIH Senologie Studienteilnahme
| Official URL: https://www.senologie.org/fhir/StructureDefinition/senologie-studienteilnahme | Version: 0.9.0 | |||
| Draft as of 2026-05-04 | Computable Name: Senologie_Studienteilnahme | |||
ResearchSubject für klinische Studienteilnahme in der Senologie aus dotbase Questionnaire 'Studien'. Bildet Studienname, Screeningstatus, Studienscreening, Studienarm, Aufklärungsdatum, Teilnahmestatus und Kontaktperson ab.
Usages:
- Examples for this Profile: ResearchSubject/Example-Studienteilnahme and ResearchSubject/Fall2-Studienteilnahme
You can also check for usages in the FHIR IG Statistics
Formal Views of Profile Content
Description of Profiles, Differentials, Snapshots and how the different presentations work.
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchSubject.status | Base | required | ResearchSubjectStatus | 📍4.0.1 | FHIR Std. |
Constraints
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchSubject | 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 | ResearchSubject | 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 | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchSubject | 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()
|
This structure is derived from ResearchSubject
| Name | Flags | Card. | Type | Description & Constraints Filter:   | ||||
|---|---|---|---|---|---|---|---|---|
  ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |||||
  id |
Σ | 0..1 | id | Logical id of this artifact | ||||
 meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| 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.
| |||||
| 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 |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
   extension:Screeningstatus |
0..1 | CodeableConcept | Screeningstatus URL: https://www.senologie.org/fhir/StructureDefinition/ex-senologie-screeningstatus Binding: VS Senologie Screeningstatus (example) | |||||
| extension:Studienscreening |
0..1 | boolean | Screening zur Studienteilnahme (K03) URL: https://www.senologie.org/fhir/StructureDefinition/ex-senologie-studienscreening | |||||
| extension:Kontakt |
0..1 | string | Kontaktperson für die Studie URL: https://www.senologie.org/fhir/StructureDefinition/ex-senologie-studienkontakt | |||||
 extension:Aufklaerungsdatum |
0..1 | date | Aufklärungsdatum URL: https://www.senologie.org/fhir/StructureDefinition/ex-senologie-aufklaerungsdatum | |||||
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for research subject in a study | ||||
| status |
?!SΣ | 1..1 | code | Teilnahmestatus Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. | ||||
| period |
SΣ | 0..1 | Period | Teilnahmezeitraum | ||||
 study |
SΣ | 1..1 | Reference(ResearchStudy) | Referenz auf die klinische Studie | ||||
| individual |
SΣ | 1..1 | Reference(Patient) | Patientin | ||||
| assignedArm |
S | 0..1 | string | Studienarm | ||||
| actualArm |
0..1 | string | What path was followed | |||||
 consent |
S | 0..1 | Reference(Consent) | Einwilligung / Aufklärung | ||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchSubject.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std. |
| ResearchSubject.status | Base | required | ResearchSubjectStatus | 📍4.0.1 | FHIR Std. |
Constraints
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchSubject | 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 | ResearchSubject | 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 | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchSubject | 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()
|
This structure is derived from ResearchSubject
Summary
Must-Support: 6 elements
Extensions
This structure refers to these extensions:
- https://www.senologie.org/fhir/StructureDefinition/ex-senologie-screeningstatus
- https://www.senologie.org/fhir/StructureDefinition/ex-senologie-studienscreening
- https://www.senologie.org/fhir/StructureDefinition/ex-senologie-studienkontakt
- https://www.senologie.org/fhir/StructureDefinition/ex-senologie-aufklaerungsdatum
Key Elements View
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchSubject.status | Base | required | ResearchSubjectStatus | 📍4.0.1 | FHIR Std. |
Constraints
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchSubject | 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 | ResearchSubject | 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 | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchSubject | 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
This structure is derived from ResearchSubject
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| 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.
| |||||
| 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 |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:Screeningstatus |
0..1 | CodeableConcept | Screeningstatus URL: https://www.senologie.org/fhir/StructureDefinition/ex-senologie-screeningstatus Binding: VS Senologie Screeningstatus (example) | |||||
| extension:Studienscreening |
0..1 | boolean | Screening zur Studienteilnahme (K03) URL: https://www.senologie.org/fhir/StructureDefinition/ex-senologie-studienscreening | |||||
| extension:Kontakt |
0..1 | string | Kontaktperson für die Studie URL: https://www.senologie.org/fhir/StructureDefinition/ex-senologie-studienkontakt | |||||
| extension:Aufklaerungsdatum |
0..1 | date | Aufklärungsdatum URL: https://www.senologie.org/fhir/StructureDefinition/ex-senologie-aufklaerungsdatum | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for research subject in a study | ||||
| status |
?!SΣ | 1..1 | code | Teilnahmestatus Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. | ||||
| period |
SΣ | 0..1 | Period | Teilnahmezeitraum | ||||
| study |
SΣ | 1..1 | Reference(ResearchStudy) | Referenz auf die klinische Studie | ||||
| individual |
SΣ | 1..1 | Reference(Patient) | Patientin | ||||
| assignedArm |
S | 0..1 | string | Studienarm | ||||
| actualArm |
0..1 | string | What path was followed | |||||
| consent |
S | 0..1 | Reference(Consent) | Einwilligung / Aufklärung | ||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchSubject.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std. |
| ResearchSubject.status | Base | required | ResearchSubjectStatus | 📍4.0.1 | FHIR Std. |
Constraints
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchSubject | 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 | ResearchSubject | 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 | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchSubject | 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()
|
This structure is derived from ResearchSubject
Summary
Must-Support: 6 elements
Extensions
This structure refers to these extensions:
- https://www.senologie.org/fhir/StructureDefinition/ex-senologie-screeningstatus
- https://www.senologie.org/fhir/StructureDefinition/ex-senologie-studienscreening
- https://www.senologie.org/fhir/StructureDefinition/ex-senologie-studienkontakt
- https://www.senologie.org/fhir/StructureDefinition/ex-senologie-aufklaerungsdatum
Other representations of profile: CSV, Excel, Schematron