R6 Ballot (2nd Draft)

Publish-box (todo)

Biomedical Research and Regulation icon Work GroupMaturity Level: N/AStandards Status: InformativeSecurity Category: Patient Compartments: Device, Patient

Mappings for the researchsubject resource (see Mappings to Other Standards for further information & status).

ResearchSubject clinical.diagnostics
    identifier FiveWs.identifier
    status FiveWs.status
        code FiveWs.status
ResearchSubject OBX
    identifier
    status
    period
    study
    subject
    subjectState
        code
        startDate
        endDate
        reason
    subjectMilestone
        milestone
        date
        reason
    assignedComparisonGroup
    actualComparisonGroup
    consent
ResearchSubject Observation[classCode=CLNTRL, moodCode=EVN]
    identifier .identifier
    status .status
        code .status
ResearchSubject StudySubject
    identifier StudySubject > Subject.identifier
    status StudySubject.statusCode
    period PerformedStudySubjectMilestone.studyReferenceDateRange
    study StudySubjectProtocolVersionRelationship
    subject StudySubject
    subjectState
        code StudySubject.statusCode
        startDate
        endDate
        reason
    subjectMilestone
        milestone
        date
        reason
    assignedComparisonGroup Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject
    actualComparisonGroup 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.