FHIR Osiris Implementation Guide - Local Development build (v2.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: ClinicalTrialSubject - Mappings

Draft as of 2024-03-21

Mappings for the clinical-trial-subject resource profile.

Mappings for Fhir-osiris to osiris (StudySubject)

ClinicalTrialSubject
ResearchSubject	StudySubject	Mapping from FHIR-osiris StudySubject to osiris StudySubject
study	OSIRIS_pivot_Treatment.ClinicalTrialId
individual	OSIRIS_pivot_Treatment.Patient_Identifier

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

ClinicalTrialSubject
ResearchSubject	StudySubject
identifier	StudySubject > Subject.identifier
status	StudySubject.statusCode
period	PerformedStudySubjectMilestone.studyReferenceDateRange
study	StudySubjectProtocolVersionRelationship
individual	StudySubject
assignedArm	Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject
actualArm	Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject
consent	ResearchStudy.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
ResearchSubject	OBX
identifier	CX / EI (occasionally, more often EI maps to a resource id or a URL)
period	DR

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

ClinicalTrialSubject
ResearchSubject	Entity. Role, or Act, Observation[classCode=CLNTRL, moodCode=EVN]
meta	n/a, N/A
implicitRules	n/a
language	n/a
text	n/a, N/A, Act.text?
contained	Entity. Role, or Act, N/A
extension	n/a, N/A
modifierExtension	n/a, N/A
identifier	n/a, II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT], .identifier
status	n/a, .status
period	n/a, IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
study	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity)
individual	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity)
assignedArm	n/a
actualArm	n/a
consent	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity)

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

ClinicalTrialSubject
ResearchSubject
identifier	FiveWs.identifier
status	FiveWs.status
period	FiveWs.planned