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Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème
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Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème - Local Development build (v0.3.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: ECLAIREResearchStudy - Mappings

Draft as of 2025-11-27

Mappings for the eclaire-researchstudy resource profile.

Mappings to Structures in this Implementation Guide

No Mappings Found

Mappings to other Structures

No Mappings Found

Other Mappings

NomBRIDG 5.1 MappingHL7 v2 MappingRIM MappingClinicalTrials.gov MappingFiveWs Pattern Mappingdoco
.. ResearchStudy
ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
OBX
  • Observation[classCode=CLNTRL
  • moodCode=EVN]
... id
... meta
N/A
... implicitRules
n/a
... language
n/a
... text
Act.text?
... contained
N/A
... Slices pour extension
N/A
.... extension:eclaire-review-date
.... extension:eclaire-approval-date
.... extension:eclaire-therapeutic-area
.... extension:eclaire-recruitment-period
.... extension:eclaire-recruitment-status
.... extension:eclaire-description-summary-r5
.... extension:eclaire-outcome-measure-r5
.... extension:eclaire-associated-party-r5
.... extension:eclaire-label-r5
... modifierExtension
N/A
... Slices pour identifier
  • No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion
  • this is arguably a different semantic)
  • CX / EI (occasionally
  • more often EI maps to a resource id or a URL)
.identifier
Organization's Unique Protocol ID; Secondary IDs
FiveWs.identifier
.... identifier:idPrimary
  • No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion
  • this is arguably a different semantic)
  • CX / EI (occasionally
  • more often EI maps to a resource id or a URL)
.identifier
Organization's Unique Protocol ID; Secondary IDs
FiveWs.identifier
..... id
n/a
..... extension
N/A
..... use
N/A
Role.code or implied by context
..... type
CX.5
Role.code or implied by context
..... system
CX.4 / EI-2-4
II.root or Role.id.root
..... value
CX.1 / EI.1
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
..... period
CX.7 + CX.8
Role.effectiveTime or implied by context
...... id
n/a
...... extension
N/A
...... start
DR.1
./low
...... end
DR.2
./high
..... assigner
  • CX.4 / (CX.4
  • CX.9
  • CX.10)
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
.... identifier:idSecondary
  • No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion
  • this is arguably a different semantic)
  • CX / EI (occasionally
  • more often EI maps to a resource id or a URL)
.identifier
Organization's Unique Protocol ID; Secondary IDs
FiveWs.identifier
..... id
n/a
..... extension
N/A
..... use
N/A
Role.code or implied by context
..... type
CX.5
Role.code or implied by context
..... system
CX.4 / EI-2-4
II.root or Role.id.root
..... value
CX.1 / EI.1
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
..... period
CX.7 + CX.8
Role.effectiveTime or implied by context
..... assigner
  • CX.4 / (CX.4
  • CX.9
  • CX.10)
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
... title
title of a document vs title of a research study)
n/a
Brief Title
... protocol
StudyProtocolDocumentVersionPublicTitle.name
.outboundRelationship[typeCode=DEFN].target
Interventions; Arm/Intervention Cross-Reference
... partOf
CompanionStudyRelationship
.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
... status
StudyOverallStatus.code
.status
FiveWs.status
... primaryPurposeType
StudyProtocolVersion.primaryPurposeTypeCode
CE/CNE/CWE
CD
... phase
StudyProtocolVersion.phaseCode
CE/CNE/CWE
CD
Study Phase
... category
InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
CE/CNE/CWE
CD
Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
... focus
InterventionalStudyProtocol.interventionTypeCode
CE/CNE/CWE
CD
Focus of Study
FiveWs.what[x]
... Slices pour condition
StudyCondition.code
CE/CNE/CWE
CD
Conditions
FiveWs.what[x]
.... condition:medDRACondition
StudyCondition.code
CE/CNE/CWE
CD
Conditions
FiveWs.what[x]
..... id
n/a
..... extension
N/A
..... coding
  • C*E.1-8
  • C*E.10-22
  • union(.
  • ./translation)
...... id
n/a
...... extension
N/A
...... system
C*E.3
./codeSystem
...... version
C*E.7
./codeSystemVersion
...... code
C*E.1
./code
...... display
C*E.2 - but note this is not well followed
CV.displayName
...... userSelected
Sometimes implied by being first
CD.codingRationale
..... text
C*E.9. But note many systems use C*E.2 for this
./originalText[mediaType/code="text/plain"]/data
.... condition:diseaseCondition
StudyCondition.code
CE/CNE/CWE
CD
Conditions
FiveWs.what[x]
..... id
n/a
..... extension
N/A
..... coding
  • C*E.1-8
  • C*E.10-22
  • union(.
  • ./translation)
..... text
C*E.9. But note many systems use C*E.2 for this
./originalText[mediaType/code="text/plain"]/data
... contact
PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
n/a
Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
.... id
n/a
.... Slices pour extension
N/A
..... extension:eclaire-contact-type
..... extension:eclaire-contact-address
..... extension:eclaire-contact-affiliation
..... extension:eclaire-contact-name
.... name
n/a
.... telecom
XTN
TEL
... relatedArtifact
  • StudyProtocolDocument
  • StudyProtocolDocumentVersion
n/a
  • Citations
  • Links
  • Available Study Data/Documents
... keyword
DocumentVersion.keywordCode; DocumentVersion.keywordText
CE/CNE/CWE
CD
Keywords
... location
StudyProtocolVersion.participatingLocationCode
CE/CNE/CWE
CD
... description
StudyProtocolDocumentVersion.publicDescription
n/a
Detailed Description
... enrollment
InterventionalStudyProtocol.interventionGroupQuantity
.participation[typeCode=SBJ].role
Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
FiveWs.subject
... period
ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
DR
.effectiveTime
Study Start Date (start); Study Completion Date (end)
FiveWs.done[x]
.... id
n/a
.... extension
N/A
.... start
DR.1
./low
.... end
DR.2
./high
... sponsor
RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
.participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
Sponsor
FiveWs.actor
... principalInvestigator
StudyInvestigator
  • The target of a resource reference is a RIM entry point (Act
  • Role
  • or Entity)
Principal Investigator
FiveWs.actor
... site
PlannedStudySite; StudySite
  • The target of a resource reference is a RIM entry point (Act
  • Role
  • or Entity)
Facility
FiveWs.where[x]
... reasonStopped
StudyOverallStatus.studyStoppedReasonCode
CE/CNE/CWE
CD
Why Study Stopped
FiveWs.why[x]
... note
No BRIDG mapping
N/A
  • .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN
  • type=ST]
... arm
Arm
n/a
Arms
.... id
n/a
.... Slices pour extension
N/A
..... extension:eclaire-arm-intervention
.... modifierExtension
N/A
.... name
Arm.name
n/a
Arm Label
.... type
Arm.typeCode
CE/CNE/CWE
CD
Arm Type
.... description
Arm.description
n/a
Arm Description
... objective
StudyObjective
n/a
.... id
n/a
.... extension
N/A
.... modifierExtension
N/A
.... name
  • No BRIDG mapping (BRIDG has a description
  • but not a name)
n/a
.... type
StudyObjective.typeCode
CE/CNE/CWE
CD

doco Documentation for this format