FHIR Osiris Implementation Guide
1.1.0 - trial-implementation

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## 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
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

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

ClinicalTrialSubject
ResearchSubject | Entity. Role, or Act, Observation[classCode=CLNTRL, moodCode=EVN]
text | Act.text?
contained | N/A
extension | N/A
modifierExtension | N/A
identifier | .identifier
status | .status

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

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