Extensions for Using Data Elements from FHIR STU3 in FHIR R4B
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Extensions for Using Data Elements from FHIR STU3 in FHIR R4B - Downloaded Version null See the Directory of published versions

Resource Profile: Profile_R3_ResearchStudy_R4B - Mappings

Page standards status: Trial-use Maturity Level: 0

Mappings for the profile-ResearchStudy resource profile.

Mappings to Structures in this Implementation Guide

No Mappings Found

Mappings to other Structures

No Mappings Found

Other Mappings

NameBRIDG 5.1 MappingHL7 v2 MappingRIM MappingFiveWs Pattern MappingClinicalTrials.gov Mappingdoco
.. ResearchStudy
ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
OBX
  • Observation[classCode=CLNTRL
  • moodCode=EVN]
clinical.diagnostics
... id
... meta
.... id
n/a
.... Slices for extension
..... extension:meta
.... versionId
.... lastUpdated
.... source
.... profile
.... security
.... tag
... implicitRules
... language
... text
Act.text?
.... id
n/a
.... Slices for extension
..... extension:text
.... status
N/A
.... div
N/A
... contained
N/A
... extension
N/A
... modifierExtension
N/A
... identifier
  • No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion
  • this is arguably a different semantic)
.identifier
FiveWs.identifier
Organization's Unique Protocol ID; Secondary IDs
.... id
n/a
.... Slices for extension
..... extension:identifier
.... 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)
Brief Title
... protocol
StudyProtocolDocumentVersionPublicTitle.name
.outboundRelationship[typeCode=DEFN].target
Interventions; Arm/Intervention Cross-Reference
.... id
n/a
.... Slices for extension
..... extension:protocol
.... reference
N/A
.... type
N/A
.... identifier
.identifier
.... display
N/A
... partOf
CompanionStudyRelationship
.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
.... id
n/a
.... Slices for extension
..... extension:partOf
.... reference
N/A
.... type
N/A
.... identifier
.identifier
.... display
N/A
... status
StudyOverallStatus.code
.status
FiveWs.status
... primaryPurposeType
StudyProtocolVersion.primaryPurposeTypeCode
... phase
StudyProtocolVersion.phaseCode
Study Phase
... category
InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
... focus
InterventionalStudyProtocol.interventionTypeCode
FiveWs.what[x]
Focus of Study
... condition
StudyCondition.code
FiveWs.what[x]
Conditions
... contact
PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
.... id
n/a
.... Slices for extension
..... extension:contact
.... name
.... telecom
... relatedArtifact
  • StudyProtocolDocument
  • StudyProtocolDocumentVersion
  • Citations
  • Links
  • Available Study Data/Documents
.... id
n/a
.... Slices for extension
..... extension:relatedArtifact
.... type
.... label
.... display
.... citation
.... url
.... document
.... resource
... keyword
DocumentVersion.keywordCode; DocumentVersion.keywordText
Keywords
... location
StudyProtocolVersion.participatingLocationCode
... description
StudyProtocolDocumentVersion.publicDescription
Detailed Description
... enrollment
InterventionalStudyProtocol.interventionGroupQuantity
.participation[typeCode=SBJ].role
FiveWs.subject
Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
.... id
n/a
.... Slices for extension
..... extension:enrollment
.... reference
N/A
.... type
N/A
.... identifier
.identifier
.... display
N/A
... period
ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
.effectiveTime
FiveWs.done[x]
Study Start Date (start); Study Completion Date (end)
.... id
n/a
.... Slices for extension
..... extension:period
.... start
DR.1
./low
.... end
DR.2
./high
... sponsor
RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
.participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
FiveWs.actor
Sponsor
.... id
n/a
.... Slices for extension
..... extension:sponsor
.... reference
N/A
.... type
N/A
.... identifier
.identifier
.... display
N/A
... principalInvestigator
StudyInvestigator
FiveWs.actor
Principal Investigator
.... id
n/a
.... Slices for extension
..... extension:principalInvestigator
.... reference
N/A
.... type
N/A
.... identifier
.identifier
.... display
N/A
... site
PlannedStudySite; StudySite
FiveWs.where[x]
Facility
.... id
n/a
.... Slices for extension
..... extension:site
.... reference
N/A
.... type
N/A
.... identifier
.identifier
.... display
N/A
... reasonStopped
StudyOverallStatus.studyStoppedReasonCode
FiveWs.why[x]
Why Study Stopped
... note
No BRIDG mapping
  • .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN
  • type=ST]
.... id
n/a
.... Slices for extension
..... extension:note
.... author[x]
N/A
Act.participant[typeCode=AUT].role
.... time
N/A
Act.effectiveTime
.... text
N/A
Act.text
... arm
Arm
Arms
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... name
Arm.name
Arm Label
.... type
Arm.typeCode
Arm Type
.... description
Arm.description
Arm Description
... objective
StudyObjective
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... name
  • No BRIDG mapping (BRIDG has a description
  • but not a name)
.... type
StudyObjective.typeCode

doco Documentation for this format