IGTTPFHIRGatewaygICS - Local Development build (v2025.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: https://ths-greifswald.de/fhir/gics/StructureDefinition/ConsentDomain | Version: 2025.2.0 | |||
| Active as of 2025-06-12 | Computable Name: ConsentDomain | |||
Copyright/Legal: Copyright 2020-2025 Unabhängige Treuhandstelle der Universitätsmedizin Greifswald |
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Erweitertes Profil der Consent Management Domain Research Study (Arbeitsgruppe Einwilligungsmanagement) zur Abbildung aller relevanten Domänen-Infos für gICS über entsprechende Extensions
Erweitertes Profil der Arbeitsgruppe Einwilligungsmanagement zur Abbildung aller relevanten Domänen-Infos für gICS
| Name | Typ | Beschreibung | Pfad |
|---|---|---|---|
| identifier | token | Eindeutiger Name (Identifikator) der Domäne | ResearchStudy.identifier |
| _profile | reference | Angabe um Ausgabeprofil festzulegen. default: https://ths-greifswald.de/fhir/StructureDefinition/gics/ResearchStudy/ConsentDomain alternativ: http://fhir.de/ConsentManagement/StructureDefinition/Domain/ResearchStudy |
ResearchStudy.meta.profile |
Zulässige Kombinationen von Suchparametern:
GET [base]/gics/ResearchStudyGET [base]/gics/ResearchStudy?_profile=http://fhir.de/ConsentManagement/StructureDefinition/Domain/ResearchStudyGET [base]/gics/ResearchStudy?identifier=MIRACUMGET [base]/gics/ResearchStudy?identifier=MIRACUM&_profile=http://fhir.de/ConsentManagement/StructureDefinition/Domain/ResearchStudyUsages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
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0..* | ConsentManagementDomainResearchStudy(2.0.2) | Investigation to increase healthcare-related patient-independent knowledge | |
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Σ | 0..1 | Meta | Metadata about the resource |
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Content/Rules for all slices | |||
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S | 0..1 | instant | Created URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/Created |
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SΣ | 0..1 | instant | When the resource version last changed |
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?!Σ | 0..1 | uri | A set of rules under which this content was created |
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1..* | Extension | Extension Slice: Unordered, Open by value:url | |
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N | 0..1 | (Complex) | Versionierungsformat der Policies, Modules und Templates für diese Consent Domain URL: http://fhir.de/ConsentManagement/StructureDefinition/VersionFormat |
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Content/Rules for all slices | |||
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N | 0..1 | Extension | Beschreibung des Formats einer Versionsangabe in textueller Form (menschenlesbar) |
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1..1 | uri | "formatString" | |
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N | 1..1 | string | Value of extension |
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N | 0..1 | Extension | Regular Expression, die das erlaubte Format von Versionen bestimmt. |
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1..1 | uri | "formatExpression" | |
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N | 1..1 | string | Value of extension |
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1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/VersionFormat" | |
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S | 0..1 | (Complex) | Logo der Studie/des Vorhabens URL: http://fhir.de/ConsentManagement/StructureDefinition/Logo |
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1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/Logo" | |
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S | 1..1 | Attachment | Value of extension |
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S | 1..* | (Complex) | Herstellung des Patientenbezugs je Kontext URL: http://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier |
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Content/Rules for all slices | |||
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SN | 1..1 | Extension | Ressource, in der ein Identifier Verwendung findet. |
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1..1 | uri | "resourceType" | |
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SN | 1..1 | Coding | Value of extension Binding: ResourceType (required) |
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SN | 0..* | Extension | Additional content defined by implementations |
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1..1 | uri | "type" | |
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SN | 1..1 | CodeableConcept | Value of extension Binding: ConsentManagementContextIdentifierType (extensible) |
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SN | 0..* | Extension | Additional content defined by implementations |
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1..1 | uri | "system" | |
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SN | 1..1 | uri | Value of extension |
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1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier" | |
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SN | 0..1 | (Complex) | Standardverfahren für die Domäne URL: http://fhir.de/ConsentManagement/StructureDefinition/ConsentMode |
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1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/ConsentMode" | |
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SN | 1..1 | Coding | Value of extension Binding: ConsentManagementConsentMode (required) |
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SΣN | 1..1 | uri | Identity of the terminology system |
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SΣN | 1..1 | code | Symbol in syntax defined by the system |
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S | 0..1 | string | Versionierungsformat für Policies einer Consent Domain URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/PolicyVersionFormat |
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S | 0..1 | string | Versionierungsformat für Module einer Consent Domain URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ModuleVersionFormat |
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S | 0..1 | string | Versionierungsformat für Templates einer Consent Domain URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/TemplateVersionFormat |
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S | 0..1 | base64Binary | Konfigurationsparameter im XML-Format, Base64-codiert URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ConfigurationProperties |
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S | 0..* | (Complex) | externalProperties URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ExternalProperty |
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S | 0..* | (Complex) | expirationProperties URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ExpirationProperty |
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S | 0..1 | Duration | validFromProperty URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ValidFromProperty |
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?!N | 0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url |
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SΣ | 1..* | Identifier | Domänen-Name |
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
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SΣ | 1..1 | uri | Instanzspezifischer Gültigkeitsbereich des Domänen-Namens Fixed Value: https://ths-greifswald.de/fhir/gics/ |
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SΣ | 1..1 | string | Name der Consent Domain Example General: 123456 |
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SΣ | 1..1 | string | Label der Consent Domain |
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?!SΣ | 1..1 | code | active | in-review Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. |
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S | 1..1 | markdown | Zweckbeschreibung der Consent Domain |
Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.extension:contextIdentifier.extension:resourceType.value[x] | Base | required | ResourceType | 📦4.0.1 | FHIR Std. |
| ResearchStudy.extension:contextIdentifier.extension:type.value[x] | Base | extensible | ConsentManagementContextIdentifierType | 📦2.0.2 | de.einwilligungsmanagement v2.0 |
| ResearchStudy.extension:consentMode.value[x] | Base | required | ConsentManagementConsentMode | 📦2.0.2 | de.einwilligungsmanagement v2.0 |
| ResearchStudy.identifier.use | Base | required | IdentifierUse | 📍4.0.1 | FHIR Std. |
| ResearchStudy.status | Base | required | ResearchStudyStatus | 📍4.0.1 | FHIR Std. |
| 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** elements | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ConsentManagementDomainResearchStudy
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
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0..* | ConsentManagementDomainResearchStudy(2.0.2) | Investigation to increase healthcare-related patient-independent knowledge | |||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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S | 0..1 | instant | Created URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/Created | ||||
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Σ | 0..1 | id | Version specific identifier | ||||
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SΣ | 0..1 | instant | When the resource version last changed | ||||
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Σ | 0..1 | uri | Identifies where the resource comes from | ||||
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Σ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
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Σ | 0..* | Coding | Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
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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". | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
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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 | |||||
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0..* | Resource | Contained, inline Resources | |||||
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1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
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N | 0..1 | (Complex) | Versionierungsformat der Policies, Modules und Templates für diese Consent Domain URL: http://fhir.de/ConsentManagement/StructureDefinition/VersionFormat | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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N | 0..1 | Extension | Beschreibung des Formats einer Versionsangabe in textueller Form (menschenlesbar) | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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1..1 | uri | "formatString" | |||||
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N | 1..1 | string | Value of extension | ||||
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N | 0..1 | Extension | Regular Expression, die das erlaubte Format von Versionen bestimmt. | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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1..1 | uri | "formatExpression" | |||||
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N | 1..1 | string | Value of extension | ||||
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1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/VersionFormat" | |||||
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S | 0..1 | (Complex) | Logo der Studie/des Vorhabens URL: http://fhir.de/ConsentManagement/StructureDefinition/Logo | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/Logo" | |||||
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S | 1..1 | Attachment | Value of extension | ||||
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S | 1..* | (Complex) | Herstellung des Patientenbezugs je Kontext URL: http://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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SN | 1..1 | Extension | Ressource, in der ein Identifier Verwendung findet. | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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1..1 | uri | "resourceType" | |||||
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SN | 1..1 | Coding | Value of extension Binding: ResourceType (required) | ||||
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SN | 0..* | Extension | Additional content defined by implementations | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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1..1 | uri | "type" | |||||
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SN | 1..1 | CodeableConcept | Value of extension Binding: ConsentManagementContextIdentifierType (extensible) | ||||
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SN | 0..* | Extension | Additional content defined by implementations | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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1..1 | uri | "system" | |||||
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SN | 1..1 | uri | Value of extension | ||||
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1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier" | |||||
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SN | 0..1 | (Complex) | Standardverfahren für die Domäne URL: http://fhir.de/ConsentManagement/StructureDefinition/ConsentMode | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/ConsentMode" | |||||
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SN | 1..1 | Coding | Value of extension Binding: ConsentManagementConsentMode (required) | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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SΣN | 1..1 | uri | Identity of the terminology system | ||||
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ΣN | 0..1 | string | Version of the system - if relevant | ||||
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SΣN | 1..1 | code | Symbol in syntax defined by the system | ||||
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ΣN | 0..1 | string | Representation defined by the system | ||||
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ΣN | 0..1 | boolean | If this coding was chosen directly by the user | ||||
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S | 0..1 | string | Versionierungsformat für Policies einer Consent Domain URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/PolicyVersionFormat | ||||
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S | 0..1 | string | Versionierungsformat für Module einer Consent Domain URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ModuleVersionFormat | ||||
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S | 0..1 | string | Versionierungsformat für Templates einer Consent Domain URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/TemplateVersionFormat | ||||
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S | 0..1 | base64Binary | Konfigurationsparameter im XML-Format, Base64-codiert URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ConfigurationProperties | ||||
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S | 0..* | (Complex) | externalProperties URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ExternalProperty | ||||
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S | 0..* | (Complex) | expirationProperties URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ExpirationProperty | ||||
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S | 0..1 | Duration | validFromProperty URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ValidFromProperty | ||||
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?!N | 0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url | ||||
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SΣ | 1..* | Identifier | Domänen-Name | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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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. | ||||
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SΣ | 1..1 | uri | Instanzspezifischer Gültigkeitsbereich des Domänen-Namens Fixed Value: https://ths-greifswald.de/fhir/gics/ | ||||
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SΣ | 1..1 | string | Name der Consent Domain Example General: 123456 | ||||
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ΣC | 0..1 | Period | Time period when id is/was valid for use Constraints: per-1 | ||||
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ΣC | 0..1 | Reference(Organization) | Organization that issued id (may be just text) Constraints: ref-1 | ||||
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SΣ | 1..1 | string | Label der Consent Domain | ||||
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ΣC | 0..* | Reference(PlanDefinition) | Steps followed in executing study Constraints: ref-1 | ||||
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ΣC | 0..* | Reference(ResearchStudy) | Part of larger study Constraints: ref-1 | ||||
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?!SΣ | 1..1 | code | active | in-review Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. | ||||
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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. | ||||
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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. | ||||
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Σ | 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. | ||||
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Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding Description: (example): Codes for medications, devices and other interventions. | ||||
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Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
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Σ | 0..* | ContactDetail | Contact details for the study | ||||
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0..* | RelatedArtifact | References and dependencies | |||||
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Σ | 0..* | CodeableConcept | Used to search for the study Binding Description: (example): Words associated with the study that may be useful in discovery. | ||||
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Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use. | ||||
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S | 1..1 | markdown | Zweckbeschreibung der Consent Domain | ||||
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ΣC | 0..* | Reference(Group) | Inclusion & exclusion criteria Constraints: ref-1 | ||||
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ΣC | 0..1 | Period | When the study began and ended Constraints: per-1 | ||||
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ΣC | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study Constraints: ref-1 | ||||
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ΣC | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study Constraints: ref-1 | ||||
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ΣC | 0..* | Reference(Location) | Facility where study activities are conducted Constraints: ref-1 | ||||
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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. | ||||
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0..* | Annotation | Comments made about the study | |||||
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0..* | BackboneElement | Defined path through the study for a subject | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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1..1 | string | Label for study arm | |||||
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0..1 | CodeableConcept | Categorization of study arm | |||||
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0..1 | string | Short explanation of study path | |||||
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0..* | BackboneElement | A goal for the study | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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0..1 | string | Label for the objective | |||||
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0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective. | |||||
Documentation for this format | ||||||||
| 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.extension:contextIdentifier.extension:resourceType.value[x] | Base | required | ResourceType | 📦4.0.1 | FHIR Std. |
| ResearchStudy.extension:contextIdentifier.extension:type.value[x] | Base | extensible | ConsentManagementContextIdentifierType | 📦2.0.2 | de.einwilligungsmanagement v2.0 |
| ResearchStudy.extension:consentMode.value[x] | Base | required | ConsentManagementConsentMode | 📦2.0.2 | de.einwilligungsmanagement v2.0 |
| ResearchStudy.identifier.use | Base | required | IdentifierUse | 📍4.0.1 | FHIR Std. |
| ResearchStudy.identifier.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. |
| 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** elements | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
| per-1 | error | ResearchStudy.identifier.period, ResearchStudy.period | If present, start SHALL have a lower value than end |
start.hasValue().not() or end.hasValue().not() or (start <= end)
|
| ref-1 | error | ResearchStudy.identifier.assigner, ResearchStudy.protocol, ResearchStudy.partOf, ResearchStudy.enrollment, ResearchStudy.sponsor, ResearchStudy.principalInvestigator, ResearchStudy.site | SHALL have a contained resource if a local reference is provided |
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
|
This structure is derived from ConsentManagementDomainResearchStudy
Summary
Mandatory: 1 element
Must-Support: 9 elements
Fixed: 1 element
Extensions
This structure refers to these extensions:
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | ConsentManagementDomainResearchStudy(2.0.2) | Investigation to increase healthcare-related patient-independent knowledge | |
![]() ![]() |
Σ | 0..1 | Meta | Metadata about the resource |
![]() ![]() ![]() |
Content/Rules for all slices | |||
![]() ![]() ![]() ![]() |
S | 0..1 | instant | Created URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/Created |
![]() ![]() ![]() |
SΣ | 0..1 | instant | When the resource version last changed |
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |
![]() ![]() ![]() |
N | 0..1 | (Complex) | Versionierungsformat der Policies, Modules und Templates für diese Consent Domain URL: http://fhir.de/ConsentManagement/StructureDefinition/VersionFormat |
![]() ![]() ![]() ![]() |
Content/Rules for all slices | |||
![]() ![]() ![]() ![]() ![]() |
N | 0..1 | Extension | Beschreibung des Formats einer Versionsangabe in textueller Form (menschenlesbar) |
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | "formatString" | |
![]() ![]() ![]() ![]() ![]() ![]() |
N | 1..1 | string | Value of extension |
![]() ![]() ![]() ![]() ![]() |
N | 0..1 | Extension | Regular Expression, die das erlaubte Format von Versionen bestimmt. |
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | "formatExpression" | |
![]() ![]() ![]() ![]() ![]() ![]() |
N | 1..1 | string | Value of extension |
![]() ![]() ![]() ![]() |
1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/VersionFormat" | |
![]() ![]() ![]() |
S | 0..1 | (Complex) | Logo der Studie/des Vorhabens URL: http://fhir.de/ConsentManagement/StructureDefinition/Logo |
![]() ![]() ![]() ![]() |
1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/Logo" | |
![]() ![]() ![]() ![]() |
S | 1..1 | Attachment | Value of extension |
![]() ![]() ![]() |
S | 1..* | (Complex) | Herstellung des Patientenbezugs je Kontext URL: http://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier |
![]() ![]() ![]() ![]() |
Content/Rules for all slices | |||
![]() ![]() ![]() ![]() ![]() |
SN | 1..1 | Extension | Ressource, in der ein Identifier Verwendung findet. |
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | "resourceType" | |
![]() ![]() ![]() ![]() ![]() ![]() |
SN | 1..1 | Coding | Value of extension Binding: ResourceType (required) |
![]() ![]() ![]() ![]() ![]() |
SN | 0..* | Extension | Additional content defined by implementations |
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | "type" | |
![]() ![]() ![]() ![]() ![]() ![]() |
SN | 1..1 | CodeableConcept | Value of extension Binding: ConsentManagementContextIdentifierType (extensible) |
![]() ![]() ![]() ![]() ![]() |
SN | 0..* | Extension | Additional content defined by implementations |
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | "system" | |
![]() ![]() ![]() ![]() ![]() ![]() |
SN | 1..1 | uri | Value of extension |
![]() ![]() ![]() ![]() |
1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier" | |
![]() ![]() ![]() |
SN | 0..1 | (Complex) | Standardverfahren für die Domäne URL: http://fhir.de/ConsentManagement/StructureDefinition/ConsentMode |
![]() ![]() ![]() ![]() |
1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/ConsentMode" | |
![]() ![]() ![]() ![]() |
SN | 1..1 | Coding | Value of extension Binding: ConsentManagementConsentMode (required) |
![]() ![]() ![]() ![]() ![]() |
SΣN | 1..1 | uri | Identity of the terminology system |
![]() ![]() ![]() ![]() ![]() |
SΣN | 1..1 | code | Symbol in syntax defined by the system |
![]() ![]() ![]() |
S | 0..1 | string | Versionierungsformat für Policies einer Consent Domain URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/PolicyVersionFormat |
![]() ![]() ![]() |
S | 0..1 | string | Versionierungsformat für Module einer Consent Domain URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ModuleVersionFormat |
![]() ![]() ![]() |
S | 0..1 | string | Versionierungsformat für Templates einer Consent Domain URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/TemplateVersionFormat |
![]() ![]() ![]() |
S | 0..1 | base64Binary | Konfigurationsparameter im XML-Format, Base64-codiert URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ConfigurationProperties |
![]() ![]() ![]() |
S | 0..* | (Complex) | externalProperties URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ExternalProperty |
![]() ![]() ![]() |
S | 0..* | (Complex) | expirationProperties URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ExpirationProperty |
![]() ![]() ![]() |
S | 0..1 | Duration | validFromProperty URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ValidFromProperty |
![]() ![]() |
?!N | 0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url |
![]() ![]() |
SΣ | 1..* | Identifier | Domänen-Name |
![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
![]() ![]() ![]() |
SΣ | 1..1 | uri | Instanzspezifischer Gültigkeitsbereich des Domänen-Namens Fixed Value: https://ths-greifswald.de/fhir/gics/ |
![]() ![]() ![]() |
SΣ | 1..1 | string | Name der Consent Domain Example General: 123456 |
![]() ![]() |
SΣ | 1..1 | string | Label der Consent Domain |
![]() ![]() |
?!SΣ | 1..1 | code | active | in-review Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. |
![]() ![]() |
S | 1..1 | markdown | Zweckbeschreibung der Consent Domain |
Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.extension:contextIdentifier.extension:resourceType.value[x] | Base | required | ResourceType | 📦4.0.1 | FHIR Std. |
| ResearchStudy.extension:contextIdentifier.extension:type.value[x] | Base | extensible | ConsentManagementContextIdentifierType | 📦2.0.2 | de.einwilligungsmanagement v2.0 |
| ResearchStudy.extension:consentMode.value[x] | Base | required | ConsentManagementConsentMode | 📦2.0.2 | de.einwilligungsmanagement v2.0 |
| ResearchStudy.identifier.use | Base | required | IdentifierUse | 📍4.0.1 | FHIR Std. |
| ResearchStudy.status | Base | required | ResearchStudyStatus | 📍4.0.1 | FHIR Std. |
| 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** elements | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
Differential View
This structure is derived from ConsentManagementDomainResearchStudy
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
![]() |
0..* | ConsentManagementDomainResearchStudy(2.0.2) | Investigation to increase healthcare-related patient-independent knowledge | |||||
![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact | ||||
![]() ![]() |
Σ | 0..1 | Meta | Metadata about the resource | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
![]() ![]() ![]() ![]() |
S | 0..1 | instant | Created URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/Created | ||||
![]() ![]() ![]() |
Σ | 0..1 | id | Version specific identifier | ||||
![]() ![]() ![]() |
SΣ | 0..1 | instant | When the resource version last changed | ||||
![]() ![]() ![]() |
Σ | 0..1 | uri | Identifies where the resource comes from | ||||
![]() ![]() ![]() |
Σ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
![]() ![]() ![]() |
Σ | 0..* | Coding | Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
![]() ![]() ![]() |
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". | ||||
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
![]() ![]() |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
![]() ![]() |
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 | |||||
![]() ![]() |
0..* | Resource | Contained, inline Resources | |||||
![]() ![]() |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() |
N | 0..1 | (Complex) | Versionierungsformat der Policies, Modules und Templates für diese Consent Domain URL: http://fhir.de/ConsentManagement/StructureDefinition/VersionFormat | ||||
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
![]() ![]() ![]() ![]() ![]() |
N | 0..1 | Extension | Beschreibung des Formats einer Versionsangabe in textueller Form (menschenlesbar) | ||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | "formatString" | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
N | 1..1 | string | Value of extension | ||||
![]() ![]() ![]() ![]() ![]() |
N | 0..1 | Extension | Regular Expression, die das erlaubte Format von Versionen bestimmt. | ||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | "formatExpression" | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
N | 1..1 | string | Value of extension | ||||
![]() ![]() ![]() ![]() |
1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/VersionFormat" | |||||
![]() ![]() ![]() |
S | 0..1 | (Complex) | Logo der Studie/des Vorhabens URL: http://fhir.de/ConsentManagement/StructureDefinition/Logo | ||||
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
![]() ![]() ![]() ![]() |
1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/Logo" | |||||
![]() ![]() ![]() ![]() |
S | 1..1 | Attachment | Value of extension | ||||
![]() ![]() ![]() |
S | 1..* | (Complex) | Herstellung des Patientenbezugs je Kontext URL: http://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier | ||||
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
![]() ![]() ![]() ![]() ![]() |
SN | 1..1 | Extension | Ressource, in der ein Identifier Verwendung findet. | ||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | "resourceType" | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
SN | 1..1 | Coding | Value of extension Binding: ResourceType (required) | ||||
![]() ![]() ![]() ![]() ![]() |
SN | 0..* | Extension | Additional content defined by implementations | ||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | "type" | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
SN | 1..1 | CodeableConcept | Value of extension Binding: ConsentManagementContextIdentifierType (extensible) | ||||
![]() ![]() ![]() ![]() ![]() |
SN | 0..* | Extension | Additional content defined by implementations | ||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | "system" | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
SN | 1..1 | uri | Value of extension | ||||
![]() ![]() ![]() ![]() |
1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier" | |||||
![]() ![]() ![]() |
SN | 0..1 | (Complex) | Standardverfahren für die Domäne URL: http://fhir.de/ConsentManagement/StructureDefinition/ConsentMode | ||||
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
![]() ![]() ![]() ![]() |
1..1 | uri | "http://fhir.de/ConsentManagement/StructureDefinition/ConsentMode" | |||||
![]() ![]() ![]() ![]() |
SN | 1..1 | Coding | Value of extension Binding: ConsentManagementConsentMode (required) | ||||
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() |
N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
![]() ![]() ![]() ![]() ![]() |
SΣN | 1..1 | uri | Identity of the terminology system | ||||
![]() ![]() ![]() ![]() ![]() |
ΣN | 0..1 | string | Version of the system - if relevant | ||||
![]() ![]() ![]() ![]() ![]() |
SΣN | 1..1 | code | Symbol in syntax defined by the system | ||||
![]() ![]() ![]() ![]() ![]() |
ΣN | 0..1 | string | Representation defined by the system | ||||
![]() ![]() ![]() ![]() ![]() |
ΣN | 0..1 | boolean | If this coding was chosen directly by the user | ||||
![]() ![]() ![]() |
S | 0..1 | string | Versionierungsformat für Policies einer Consent Domain URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/PolicyVersionFormat | ||||
![]() ![]() ![]() |
S | 0..1 | string | Versionierungsformat für Module einer Consent Domain URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ModuleVersionFormat | ||||
![]() ![]() ![]() |
S | 0..1 | string | Versionierungsformat für Templates einer Consent Domain URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/TemplateVersionFormat | ||||
![]() ![]() ![]() |
S | 0..1 | base64Binary | Konfigurationsparameter im XML-Format, Base64-codiert URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ConfigurationProperties | ||||
![]() ![]() ![]() |
S | 0..* | (Complex) | externalProperties URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ExternalProperty | ||||
![]() ![]() ![]() |
S | 0..* | (Complex) | expirationProperties URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ExpirationProperty | ||||
![]() ![]() ![]() |
S | 0..1 | Duration | validFromProperty URL: https://ths-greifswald.de/fhir/StructureDefinition/gics/ValidFromProperty | ||||
![]() ![]() |
?!N | 0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url | ||||
![]() ![]() |
SΣ | 1..* | Identifier | Domänen-Name | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
![]() ![]() ![]() |
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. | ||||
![]() ![]() ![]() |
SΣ | 1..1 | uri | Instanzspezifischer Gültigkeitsbereich des Domänen-Namens Fixed Value: https://ths-greifswald.de/fhir/gics/ | ||||
![]() ![]() ![]() |
SΣ | 1..1 | string | Name der Consent Domain Example General: 123456 | ||||
![]() ![]() ![]() |
ΣC | 0..1 | Period | Time period when id is/was valid for use Constraints: per-1 | ||||
![]() ![]() ![]() |
ΣC | 0..1 | Reference(Organization) | Organization that issued id (may be just text) Constraints: ref-1 | ||||
![]() ![]() |
SΣ | 1..1 | string | Label der Consent Domain | ||||
![]() ![]() |
ΣC | 0..* | Reference(PlanDefinition) | Steps followed in executing study Constraints: ref-1 | ||||
![]() ![]() |
ΣC | 0..* | Reference(ResearchStudy) | Part of larger study Constraints: ref-1 | ||||
![]() ![]() |
?!SΣ | 1..1 | code | active | in-review Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. | ||||
![]() ![]() |
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. | ||||
![]() ![]() |
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. | ||||
![]() ![]() |
Σ | 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. | ||||
![]() ![]() |
Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding Description: (example): Codes for medications, devices and other interventions. | ||||
![]() ![]() |
Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
![]() ![]() |
Σ | 0..* | ContactDetail | Contact details for the study | ||||
![]() ![]() |
0..* | RelatedArtifact | References and dependencies | |||||
![]() ![]() |
Σ | 0..* | CodeableConcept | Used to search for the study Binding Description: (example): Words associated with the study that may be useful in discovery. | ||||
![]() ![]() |
Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use. | ||||
![]() ![]() |
S | 1..1 | markdown | Zweckbeschreibung der Consent Domain | ||||
![]() ![]() |
ΣC | 0..* | Reference(Group) | Inclusion & exclusion criteria Constraints: ref-1 | ||||
![]() ![]() |
ΣC | 0..1 | Period | When the study began and ended Constraints: per-1 | ||||
![]() ![]() |
ΣC | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study Constraints: ref-1 | ||||
![]() ![]() |
ΣC | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study Constraints: ref-1 | ||||
![]() ![]() |
ΣC | 0..* | Reference(Location) | Facility where study activities are conducted Constraints: ref-1 | ||||
![]() ![]() |
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. | ||||
![]() ![]() |
0..* | Annotation | Comments made about the study | |||||
![]() ![]() |
0..* | BackboneElement | Defined path through the study for a subject | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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1..1 | string | Label for study arm | |||||
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0..1 | CodeableConcept | Categorization of study arm | |||||
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0..1 | string | Short explanation of study path | |||||
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0..* | BackboneElement | A goal for the study | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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0..1 | string | Label for the objective | |||||
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0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective. | |||||
Documentation for this format | ||||||||
| 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.extension:contextIdentifier.extension:resourceType.value[x] | Base | required | ResourceType | 📦4.0.1 | FHIR Std. |
| ResearchStudy.extension:contextIdentifier.extension:type.value[x] | Base | extensible | ConsentManagementContextIdentifierType | 📦2.0.2 | de.einwilligungsmanagement v2.0 |
| ResearchStudy.extension:consentMode.value[x] | Base | required | ConsentManagementConsentMode | 📦2.0.2 | de.einwilligungsmanagement v2.0 |
| ResearchStudy.identifier.use | Base | required | IdentifierUse | 📍4.0.1 | FHIR Std. |
| ResearchStudy.identifier.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. |
| 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** elements | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
| per-1 | error | ResearchStudy.identifier.period, ResearchStudy.period | If present, start SHALL have a lower value than end |
start.hasValue().not() or end.hasValue().not() or (start <= end)
|
| ref-1 | error | ResearchStudy.identifier.assigner, ResearchStudy.protocol, ResearchStudy.partOf, ResearchStudy.enrollment, ResearchStudy.sponsor, ResearchStudy.principalInvestigator, ResearchStudy.site | SHALL have a contained resource if a local reference is provided |
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
|
This structure is derived from ConsentManagementDomainResearchStudy
Summary
Mandatory: 1 element
Must-Support: 9 elements
Fixed: 1 element
Extensions
This structure refers to these extensions:
Other representations of profile: CSV, Excel, Schematron
In der Extension configurationProperties kann die Konfiguration der Domäne im XML-Format repräsentiert werden. Diese XML-Struktur ist base64-codiert enthalten.