R4 Draft for Comment

This page is part of the FHIR Specification (v3.2.0: R4 Ballot 1). 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

8.25.7 Resource ResearchStudy - Mappings

Biomedical Research and Regulation Work GroupMaturity Level: N/ABallot Status: Informative Compartments: Practitioner

Mappings:

FiveWs Pattern

HL7 v2 Mapping

RIM Mapping

ClinicalTrials.gov Mapping

Mappings for the researchstudy resource.

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

ResearchStudy
    identifierFiveWs.identifier
    statusFiveWs.status
    focusFiveWs.what[x]
    enrollmentFiveWs.subject[x]
    periodFiveWs.done[x]
    sponsorFiveWs.actor
    principalInvestigatorFiveWs.actor
    siteFiveWs.where[x]
    reasonStoppedFiveWs.why[x]

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

ResearchStudyOBX
    identifier
    title
    protocol
    partOf
    status
    primaryPurposeType
    phase
    category
    focus
    condition
    contact
    relatedArtifact
    keyword
    location
    description
    enrollment
    period
    sponsor
    principalInvestigator
    site
    reasonStopped
    note
    arm
        name
        type
        description
    objective
        name
        type

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

ResearchStudyObservation[classCode=CLNTRL, moodCode=EVN]
    identifier.identifier
    protocol.outboundRelationship[typeCode=DEFN].target
    partOf.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
    status.status
    enrollment.participation[typeCode=SBJ].role
    period.effectiveTime
    sponsor.participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
    note.inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]

8.25.7.4 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
    primaryPurposeType
    phaseStudy Phase
    categoryStudy Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
    focusFocus of Study
    conditionConditions
    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
    location
    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
        typeArm Type
        descriptionArm Description
    objective
        name
        type