Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Resource Profile: StudyComponent - Mappings

Page standards status: Trial-use Maturity Level: 1

Mappings for the study-component resource profile.

Mappings to Structures in this Implementation Guide

No Mappings Found

Mappings to other Structures

No Mappings Found

Other Mappings

NameFiveWs Pattern MappingBRIDG 5.1 MappingHL7 V2 MappingRIM MappingClinicalTrials.gov Mappingdoco
ResearchStudy
clinical.diagnostics
ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
OBX
  • Entity
  • Role
  • or Act
  • Observation[classCode=CLNTRL
  • moodCode=EVN]
ResearchStudy / id
ResearchStudy / meta
ResearchStudy / implicitRules
ResearchStudy / language
ResearchStudy / text
Act.text?
ResearchStudy / contained
N/A
ResearchStudy / Slices for extension
N/A
ResearchStudy / Slices for extension / extension:publicationStatus
ResearchStudy / Slices for extension / extension:author
ResearchStudy / Slices for extension / extension:confidentialityStatement
ResearchStudy / Slices for extension / extension:saeReportingMethod
ResearchStudy / Slices for extension / extension:studyAmendment
ResearchStudy / modifierExtension
N/A
ResearchStudy / url
ResearchStudy / identifier
FiveWs.identifier
  • No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion
  • this is arguably a different semantic)
.identifier
Organization's Unique Protocol ID; Secondary IDs
ResearchStudy / version
ResearchStudy / name
ResearchStudy / title
title of a document vs title of a research study)
Brief Title
ResearchStudy / label
ResearchStudy / label / id
n/a
ResearchStudy / label / extension
n/a
ResearchStudy / label / modifierExtension
N/A
ResearchStudy / label / type
ResearchStudy / label / value
ResearchStudy / label / language
ResearchStudy / protocol
StudyProtocolDocumentVersionPublicTitle.name
.outboundRelationship[typeCode=DEFN].target
Interventions; Arm/Intervention Cross-Reference
ResearchStudy / partOf
CompanionStudyRelationship
.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
ResearchStudy / citeAs
ResearchStudy / relatesTo
ResearchStudy / relatesTo / id
n/a
ResearchStudy / relatesTo / Slices for extension
n/a
ResearchStudy / relatesTo / Slices for extension / extension:quotation
ResearchStudy / relatesTo / Slices for extension / extension:classifier
ResearchStudy / relatesTo / modifierExtension
N/A
ResearchStudy / relatesTo / type
ResearchStudy / relatesTo / target[x]
ResearchStudy / date
ResearchStudy / status
FiveWs.status
StudyOverallStatus.code
.status
ResearchStudy / purposeType
StudyProtocolVersion.primaryPurposeTypeCode
ResearchStudy / phase
StudyProtocolVersion.phaseCode
Study Phase
ResearchStudy / studyDesign
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
ResearchStudy / focus
ResearchStudy / condition
FiveWs.what[x]
StudyCondition.code
Conditions
ResearchStudy / keyword
DocumentVersion.keywordCode; DocumentVersion.keywordText
Keywords
ResearchStudy / region
StudyProtocolVersion.participatingLocationCode
ResearchStudy / descriptionSummary
ResearchStudy / description
StudyProtocolDocumentVersion.publicDescription
Detailed Description
ResearchStudy / period
FiveWs.done[x]
ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
.effectiveTime
Study Start Date (start); Study Completion Date (end)
ResearchStudy / site
FiveWs.where[x]
PlannedStudySite; StudySite
Facility
ResearchStudy / note
No BRIDG mapping
  • .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN
  • type=ST]
ResearchStudy / classifier
ResearchStudy / associatedParty
ResearchStudy / associatedParty / id
n/a
ResearchStudy / associatedParty / extension
n/a
ResearchStudy / associatedParty / modifierExtension
N/A
ResearchStudy / associatedParty / name
ResearchStudy / associatedParty / role
ResearchStudy / associatedParty / period
ResearchStudy / associatedParty / classifier
ResearchStudy / associatedParty / party
ResearchStudy / progressStatus
ResearchStudy / progressStatus / id
n/a
ResearchStudy / progressStatus / extension
n/a
ResearchStudy / progressStatus / modifierExtension
N/A
ResearchStudy / progressStatus / state
ResearchStudy / progressStatus / actual
ResearchStudy / progressStatus / period
ResearchStudy / whyStopped
FiveWs.why[x]
StudyOverallStatus.studyStoppedReasonCode
Why Study Stopped
ResearchStudy / recruitment
FiveWs.subject
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)
ResearchStudy / recruitment / id
n/a
ResearchStudy / recruitment / extension
n/a
ResearchStudy / recruitment / modifierExtension
N/A
ResearchStudy / recruitment / targetNumber
ResearchStudy / recruitment / actualNumber
ResearchStudy / recruitment / eligibility
ResearchStudy / recruitment / actualGroup
FiveWs.subject
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)
ResearchStudy / recruitment / description
ResearchStudy / comparisonGroup
Arm
Arms
ResearchStudy / comparisonGroup / id
n/a
ResearchStudy / comparisonGroup / extension
n/a
ResearchStudy / comparisonGroup / modifierExtension
N/A
ResearchStudy / comparisonGroup / targetNumber
ResearchStudy / comparisonGroup / actualNumber
ResearchStudy / comparisonGroup / eligibility
ResearchStudy / comparisonGroup / observedGroup
ResearchStudy / comparisonGroup / name
ResearchStudy / comparisonGroup / description
ResearchStudy / objective
StudyObjective
ResearchStudy / objective / id
n/a
ResearchStudy / objective / extension
n/a
ResearchStudy / objective / modifierExtension
N/A
ResearchStudy / objective / name
  • No BRIDG mapping (BRIDG has a description
  • but not a name)
ResearchStudy / objective / type
StudyObjective.typeCode
ResearchStudy / objective / description
ResearchStudy / objective / outcomeMeasure
ResearchStudy / objective / outcomeMeasure / id
n/a
ResearchStudy / objective / outcomeMeasure / extension
n/a
ResearchStudy / objective / outcomeMeasure / modifierExtension
N/A
ResearchStudy / objective / outcomeMeasure / name
ResearchStudy / objective / outcomeMeasure / type
ResearchStudy / objective / outcomeMeasure / description
ResearchStudy / objective / outcomeMeasure / endpoint
ResearchStudy / objective / outcomeMeasure / population
ResearchStudy / objective / outcomeMeasure / intervention
ResearchStudy / objective / outcomeMeasure / comparator
ResearchStudy / objective / outcomeMeasure / summaryMeasure
ResearchStudy / objective / outcomeMeasure / endpointAnalysisPlan
ResearchStudy / objective / outcomeMeasure / eventHandling
ResearchStudy / objective / outcomeMeasure / eventHandling / id
n/a
ResearchStudy / objective / outcomeMeasure / eventHandling / extension
n/a
ResearchStudy / objective / outcomeMeasure / eventHandling / modifierExtension
N/A
ResearchStudy / objective / outcomeMeasure / eventHandling / event
ResearchStudy / objective / outcomeMeasure / eventHandling / group
ResearchStudy / objective / outcomeMeasure / eventHandling / handling
ResearchStudy / objective / outcomeMeasure / eventHandling / description
ResearchStudy / result

doco Documentation for this format