Release 5 Preview #2

This page is part of the FHIR Specification (v4.4.0: R5 Preview #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial Use Compartments: Not linked to any defined compartments

Dependency Graph for RegulatedAuthorization FMM level 1

NameCard.TypeDependency Analysis
.. RegulatedAuthorization DomainResource
... identifier 0..*Identifier
... subject 0..1Reference(MedicinalProductDefinition | PackagedProductDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition)Type Warning: (ResearchStudy = FMM0-Trial Use vs. Element = FMM1-Trial Use)
... type 0..1CodeableConcept
... region 0..*CodeableConcept
... status 0..1CodeableConcept
... statusDate 0..1dateTime
... validityPeriod 0..1Period
... indication[x] 0..1
.... indicationCodeableConceptCodeableConcept
.... indicationReferenceReference(ClinicalUseIssue
... intendedUse 0..1CodeableConcept
... basis 0..*CodeableConcept
... relatedDate 0..*BackboneElement
.... date[x] 1..1
..... datePeriodPeriod
..... dateDateTimedateTime
.... type 1..1CodeableConcept
... jurisdictionalAuthorization 0..*Reference(RegulatedAuthorization)
... holder 0..1Reference(Organization)
... regulator 0..1Reference(Organization)
... case 0..1BackboneElement
.... identifier 0..1Identifier
.... type 0..1CodeableConcept
.... status 0..1CodeableConcept
.... date[x] 0..1
..... datePeriodPeriod
..... dateDateTimedateTime
.... application 0..*see case