Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème - Local Development build (v0.2.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: ECLAIREResearchStudy - Mappings

Draft as of 2023-12-04

Mappings for the eclaire-researchstudy resource profile.

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

ECLAIREResearchStudy
ResearchStudy	ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
identifier	No 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)
title	No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
protocol	StudyProtocolDocumentVersionPublicTitle.name
partOf	CompanionStudyRelationship
status	StudyOverallStatus.code
primaryPurposeType	StudyProtocolVersion.primaryPurposeTypeCode
phase	StudyProtocolVersion.phaseCode
category	InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
focus	InterventionalStudyProtocol.interventionTypeCode
condition	StudyCondition.code
condition (medDRACondition)	StudyCondition.code
condition (diseaseCondition)	StudyCondition.code
contact	PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
relatedArtifact	StudyProtocolDocument, StudyProtocolDocumentVersion
keyword	DocumentVersion.keywordCode; DocumentVersion.keywordText
location	StudyProtocolVersion.participatingLocationCode
description	StudyProtocolDocumentVersion.publicDescription
enrollment	InterventionalStudyProtocol.interventionGroupQuantity
period	ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
sponsor	RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
principalInvestigator	StudyInvestigator
site	PlannedStudySite; StudySite
reasonStopped	StudyOverallStatus.studyStoppedReasonCode
note	No BRIDG mapping
arm	Arm
name	Arm.name
type	Arm.typeCode
description	Arm.description
objective	StudyObjective
name	No BRIDG mapping (BRIDG has a description, but not a name)
type	StudyObjective.typeCode

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

ECLAIREResearchStudy
ResearchStudy	OBX
identifier	CX / EI (occasionally, more often EI maps to a resource id or a URL)
identifier (idPrimary)	CX / EI (occasionally, more often EI maps to a resource id or a URL)
use	N/A
type	CE/CNE/CWE, CX.5
system	CX.4 / EI-2-4
value	CX.1 / EI.1
period	DR, CX.7 + CX.8
assigner	CX.4 / (CX.4,CX.9,CX.10)
identifier (idSecondary)	CX / EI (occasionally, more often EI maps to a resource id or a URL)
use	N/A
type	CE/CNE/CWE, CX.5
system	CX.4 / EI-2-4
value	CX.1 / EI.1
period	DR, CX.7 + CX.8
assigner	CX.4 / (CX.4,CX.9,CX.10)
primaryPurposeType	CE/CNE/CWE
phase	CE/CNE/CWE
category	CE/CNE/CWE
focus	CE/CNE/CWE
condition	CE/CNE/CWE
condition (medDRACondition)	CE/CNE/CWE
coding	CE/CNE/CWE subset one of the sets of component 1-3 or 4-6, C*E.1-8, C*E.10-22
system	C*E.3
version	C*E.7
code	C*E.1
display	C*E.2 - but note this is not well followed
userSelected	Sometimes implied by being first
text	C*E.9. But note many systems use C*E.2 for this
condition (diseaseCondition)	CE/CNE/CWE
coding	CE/CNE/CWE subset one of the sets of component 1-3 or 4-6, C*E.1-8, C*E.10-22
text	C*E.9. But note many systems use C*E.2 for this
contact
telecom	XTN
keyword	CE/CNE/CWE
location	CE/CNE/CWE
period	DR
reasonStopped	CE/CNE/CWE
note	N/A
arm
type	CE/CNE/CWE
objective
type	CE/CNE/CWE

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

ECLAIREResearchStudy
ResearchStudy	Entity. Role, or Act, Observation[classCode=CLNTRL, moodCode=EVN]
meta	n/a, N/A
implicitRules	n/a
language	n/a
text	n/a, N/A, Act.text?
contained	Entity. Role, or Act, N/A
extension	n/a, N/A
modifierExtension	n/a, N/A
identifier	n/a, II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT], .identifier
identifier (idPrimary)	n/a, II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT], .identifier
id	n/a
extension	n/a, N/A
use	n/a, Role.code or implied by context
type	n/a, CD, Role.code or implied by context
system	n/a, II.root or Role.id.root
value	n/a, II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
period	n/a, IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"], Role.effectiveTime or implied by context
assigner	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity), II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
identifier (idSecondary)	n/a, II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT], .identifier
id	n/a
extension	n/a, N/A
use	n/a, Role.code or implied by context
type	n/a, CD, Role.code or implied by context
system	n/a, II.root or Role.id.root
value	n/a, II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
period	n/a, IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"], Role.effectiveTime or implied by context
assigner	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity), II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
title	n/a
protocol	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity), .outboundRelationship[typeCode=DEFN].target
partOf	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity), .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
status	n/a, .status
primaryPurposeType	n/a, CD
phase	n/a, CD
category	n/a, CD
focus	n/a, CD
condition	n/a, CD
condition (medDRACondition)	n/a, CD
id	n/a
extension	n/a, N/A
coding	n/a, CV, union(., ./translation)
id	n/a
extension	n/a, N/A
system	n/a, ./codeSystem
version	n/a, ./codeSystemVersion
code	n/a, ./code
display	n/a, CV.displayName
userSelected	n/a, CD.codingRationale
text	n/a, ./originalText[mediaType/code="text/plain"]/data
condition (diseaseCondition)	n/a, CD
id	n/a
extension	n/a, N/A
coding	n/a, CV, union(., ./translation)
text	n/a, ./originalText[mediaType/code="text/plain"]/data
contact	n/a
id	n/a
extension	n/a, N/A
name	n/a
telecom	n/a, TEL
relatedArtifact	n/a
keyword	n/a, CD
location	n/a, CD
description	n/a
enrollment	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity), .participation[typeCode=SBJ].role
period	n/a, IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"], .effectiveTime
sponsor	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity), .participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
principalInvestigator	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity)
site	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity)
reasonStopped	n/a, CD
note	n/a, Act, .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
arm	n/a
id	n/a
extension	n/a, N/A
modifierExtension	n/a, N/A
name	n/a
type	n/a, CD
description	n/a
objective	n/a
id	n/a
extension	n/a, N/A
modifierExtension	n/a, N/A
name	n/a
type	n/a, CD

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

ECLAIREResearchStudy
ResearchStudy
identifier	Organization's Unique Protocol ID; Secondary IDs
identifier (idPrimary)	Organization's Unique Protocol ID; Secondary IDs
identifier (idSecondary)	Organization's Unique Protocol ID; Secondary IDs
title	Brief Title
protocol	Interventions; Arm/Intervention Cross-Reference
phase	Study Phase
category	Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
focus	Focus of Study
condition	Conditions
condition (medDRACondition)	Conditions
condition (diseaseCondition)	Conditions
contact	Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
relatedArtifact	Citations, Links, Available Study Data/Documents
keyword	Keywords
description	Detailed Description
enrollment	Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
period	Study Start Date (start); Study Completion Date (end)
sponsor	Sponsor
principalInvestigator	Principal Investigator
site	Facility
reasonStopped	Why Study Stopped
arm	Arms
name	Arm Label
type	Arm Type
description	Arm Description

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

ECLAIREResearchStudy
ResearchStudy
identifier	FiveWs.identifier
identifier (idPrimary)	FiveWs.identifier
identifier (idSecondary)	FiveWs.identifier
status	FiveWs.status
focus	FiveWs.what[x]
condition	FiveWs.what[x]
condition (medDRACondition)	FiveWs.what[x]
condition (diseaseCondition)	FiveWs.what[x]
enrollment	FiveWs.subject[x], FiveWs.subject
period	FiveWs.done[x]
sponsor	FiveWs.actor
principalInvestigator	FiveWs.actor
site	FiveWs.where[x]
reasonStopped	FiveWs.why[x]