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FHIR Osiris Implementation Guide
1.1.0 - trial-implementation

This page is part of the OSIRIS FHIR Implementation Guide (v1.1.0: 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

Resource Profile: ClinicalTrialSubject - Mappings

Draft as of 2025-04-03

Mappings for the clinical-trial-subject resource profile.

Mappings for Fhir-osiris to osiris (StudySubject)

ClinicalTrialSubject
ResearchSubjectStudySubject

Mapping from FHIR-osiris StudySubject to osiris StudySubject

   studyOSIRIS_pivot_Treatment.ClinicalTrialId
   individualOSIRIS_pivot_Treatment.Patient_Identifier

Mappings for BRIDG 5.1 Mapping (https://bridgmodel.nci.nih.gov)

ClinicalTrialSubject
ResearchSubjectStudySubject
   identifierStudySubject > Subject.identifier
   statusStudySubject.statusCode
   periodPerformedStudySubjectMilestone.studyReferenceDateRange
   studyStudySubjectProtocolVersionRelationship
   individualStudySubject
   assignedArmArm > ExperimentalUnit > BiologicEntity > Subject > StudySubject
   actualArmArm > ExperimentalUnit > BiologicEntity > Subject > StudySubject
   consentResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource.

Mappings for HL7 v2 Mapping (http://hl7.org/v2)

ClinicalTrialSubject
ResearchSubjectOBX

Mappings for RIM Mapping (http://hl7.org/v3)

ClinicalTrialSubject
ResearchSubjectEntity. Role, or Act, Observation[classCode=CLNTRL, moodCode=EVN]
   textAct.text?
   containedN/A
   extensionN/A
   modifierExtensionN/A
   identifier.identifier
   status.status

Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

ClinicalTrialSubject
ResearchSubject
   identifierFiveWs.identifier
   statusFiveWs.status
   periodFiveWs.planned