Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème
0.2.0 - trial-use France flag

This page is part of the Implementation Guide FHIR pour le projet ECLAIRE, base de données qui recense les essais cliniques en France (v0.2.0: Release) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: ECLAIREResearchStudy - Mappings

Draft as of 2023-10-24

Mappings for the eclaire-researchstudy resource profile.

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

ECLAIREResearchStudy
ResearchStudyObservationalStudyProtocolVersion; Study; StudyProtocolVersion
   identifierNo BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
   identifier (idPrimary)No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
   identifier (idSecondary)No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
   titleNo BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
   protocolStudyProtocolDocumentVersionPublicTitle.name
   partOfCompanionStudyRelationship
   statusStudyOverallStatus.code
   primaryPurposeTypeStudyProtocolVersion.primaryPurposeTypeCode
   phaseStudyProtocolVersion.phaseCode
   categoryInterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
   focusInterventionalStudyProtocol.interventionTypeCode
   conditionStudyCondition.code
   condition (medDRACondition)StudyCondition.code
   condition (diseaseCondition)StudyCondition.code
   contactPointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
   relatedArtifactStudyProtocolDocument, StudyProtocolDocumentVersion
   keywordDocumentVersion.keywordCode; DocumentVersion.keywordText
   locationStudyProtocolVersion.participatingLocationCode
   descriptionStudyProtocolDocumentVersion.publicDescription
   enrollmentInterventionalStudyProtocol.interventionGroupQuantity
   periodProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
   sponsorRegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
   principalInvestigatorStudyInvestigator
   sitePlannedStudySite; StudySite
   reasonStoppedStudyOverallStatus.studyStoppedReasonCode
   noteNo BRIDG mapping
   armArm
      nameArm.name
      typeArm.typeCode
      descriptionArm.description
   objectiveStudyObjective
      nameNo BRIDG mapping (BRIDG has a description, but not a name)
      typeStudyObjective.typeCode

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

ECLAIREResearchStudy
ResearchStudyOBX
   identifier
   identifier (idPrimary)
      useN/A
      typeCX.5
      systemCX.4 / EI-2-4
      valueCX.1 / EI.1
      periodCX.7 + CX.8
      assignerCX.4 / (CX.4,CX.9,CX.10)
   identifier (idSecondary)
      useN/A
      typeCX.5
      systemCX.4 / EI-2-4
      valueCX.1 / EI.1
      periodCX.7 + CX.8
      assignerCX.4 / (CX.4,CX.9,CX.10)
   condition
   condition (medDRACondition)
      codingC*E.1-8, C*E.10-22
         systemC*E.3
         versionC*E.7
         codeC*E.1
         displayC*E.2 - but note this is not well followed
         userSelectedSometimes implied by being first
      textC*E.9. But note many systems use C*E.2 for this
   condition (diseaseCondition)
      codingC*E.1-8, C*E.10-22
      textC*E.9. But note many systems use C*E.2 for this

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

ECLAIREResearchStudy
ResearchStudyEntity. Role, or Act, Observation[classCode=CLNTRL, moodCode=EVN]
   textAct.text?
   containedN/A
   modifierExtensionN/A
   identifier.identifier
   identifier (idPrimary).identifier
      idn/a
      extensionn/a
      useRole.code or implied by context
      typeRole.code or implied by context
      systemII.root or Role.id.root
      valueII.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
      periodRole.effectiveTime or implied by context
      assignerII.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
   identifier (idSecondary).identifier
      idn/a
      extensionn/a
      useRole.code or implied by context
      typeRole.code or implied by context
      systemII.root or Role.id.root
      valueII.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
      periodRole.effectiveTime or implied by context
      assignerII.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
   protocol.outboundRelationship[typeCode=DEFN].target
   partOf.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
   status.status
   condition
   condition (medDRACondition)
      idn/a
      extensionn/a
      codingunion(., ./translation)
         idn/a
         extensionn/a
         system./codeSystem
         version./codeSystemVersion
         code./code
         displayCV.displayName
         userSelectedCD.codingRationale
      text./originalText[mediaType/code="text/plain"]/data
   condition (diseaseCondition)
      idn/a
      extensionn/a
      codingunion(., ./translation)
      text./originalText[mediaType/code="text/plain"]/data
   contact
      idn/a
      extensionn/a
   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]
   arm
      idn/a
      extensionn/a
      modifierExtensionN/A
   objective
      idn/a
      extensionn/a
      modifierExtensionN/A

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

ECLAIREResearchStudy
ResearchStudy
   identifierOrganization's Unique Protocol ID; Secondary IDs
   identifier (idPrimary)Organization's Unique Protocol ID; Secondary IDs
   identifier (idSecondary)Organization's Unique Protocol ID; Secondary IDs
   titleBrief Title
   protocolInterventions; Arm/Intervention Cross-Reference
   phaseStudy Phase
   categoryStudy Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
   focusFocus of Study
   conditionConditions
   condition (medDRACondition)Conditions
   condition (diseaseCondition)Conditions
   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
   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
   armArms
      nameArm Label
      typeArm Type
      descriptionArm Description

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

ECLAIREResearchStudy
ResearchStudy
   identifierFiveWs.identifier
   identifier (idPrimary)FiveWs.identifier
   identifier (idSecondary)FiveWs.identifier
   statusFiveWs.status
   focusFiveWs.what[x]
   conditionFiveWs.what[x]
   condition (medDRACondition)FiveWs.what[x]
   condition (diseaseCondition)FiveWs.what[x]
   enrollmentFiveWs.subject[x], FiveWs.subject
   periodFiveWs.done[x]
   sponsorFiveWs.actor
   principalInvestigatorFiveWs.actor
   siteFiveWs.where[x]
   reasonStoppedFiveWs.why[x]