FHIR Release 3 (STU)

This page is part of the FHIR Specification (v3.0.2: STU 3). 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 R4 R3

8.22.6 Resource ResearchStudy - Mappings

Regulated Clinical Research Information Management Work GroupMaturity Level: N/ABallot Status: InformativeCompartments: Practitioner

Mappings:

RIM Mapping

HL7 v2 Mapping

ClinicalTrials.gov Mapping

Mappings for the researchstudy resource.

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

ResearchStudyObservation[classCode=CLNTRL, moodCode=EVN]
    identifier.identifier
    title
    protocol.outboundRelationship[typeCode=DEFN].target
    partOf.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
    status.status
    category
    focus
    contact
    relatedArtifact
    keyword
    jurisdiction
    description
    enrollment
    period
    sponsor
    principalInvestigator
    site
    reasonStopped
    note
    arm
        name
        code
        description

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

ResearchStudyOBX
    identifier
    title
    protocol
    partOf
    status
    category
    focus
    contact
    relatedArtifact
    keyword
    jurisdiction
    description
    enrollment
    period
    sponsor
    principalInvestigator
    site
    reasonStopped
    note
    arm
        name
        code
        description

8.22.6.3 Mappings for ClinicalTrials.gov Mapping (http://clinicaltrials.gov)

ResearchStudy
    identifierOrganization's Unique Protocol ID; Secondary IDs
    titleBrief Title
    protocolInterventions; Arm/Intervention Cross-Reference
    partOf
    status
    categoryStudy Type; Primary Purpose; Study Phase; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
    focusConditions or Focus of Study
    contactCentral Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
    relatedArtifactCitations, Links, Available Study Data/Documents
    keywordKeywords
    jurisdiction
    descriptionDetailed Description
    enrollmentEnrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
    periodStudy Start Date (start); Study Completion Date (end)
    sponsorSponsor
    principalInvestigatorPrincipal Investigator
    siteFacility
    reasonStoppedWhy Study Stopped
    note
    armArms
        nameArm Label
        codeArm Type
        descriptionArm Description