Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot International flag

Pharmaceutical Research Protocol (Vulcan UDP), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

Resource Profile: StudyDesign - Mappings

Page standards status: Draft Maturity Level: 1

Mappings for the study-design 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]
... id
... meta
... implicitRules
... language
... text
Act.text?
... contained
N/A
... Slices for extension
.... extension:author
.... extension:RelatesToWithQuotation
.... extension:confidentialityStatement
.... extension:saeReportingMethod
.... extension:studyAmendment
... modifierExtension
N/A
... url
... 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
... version
... name
... title
title of a document vs title of a research study)
Brief Title
... label
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... type
.... value
... protocol
StudyProtocolDocumentVersionPublicTitle.name
.outboundRelationship[typeCode=DEFN].target
Interventions; Arm/Intervention Cross-Reference
... partOf
CompanionStudyRelationship
.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
... citeAs
... relatesTo
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... type
.... target[x]
... date
... status
FiveWs.status
StudyOverallStatus.code
.status
... primaryPurposeType
StudyProtocolVersion.primaryPurposeTypeCode
... phase
StudyProtocolVersion.phaseCode
Study Phase
... 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
... focus
... condition
FiveWs.what[x]
StudyCondition.code
Conditions
... keyword
DocumentVersion.keywordCode; DocumentVersion.keywordText
Keywords
... region
StudyProtocolVersion.participatingLocationCode
... descriptionSummary
... description
StudyProtocolDocumentVersion.publicDescription
Detailed Description
... period
FiveWs.done[x]
ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
.effectiveTime
Study Start Date (start); Study Completion Date (end)
... site
FiveWs.where[x]
PlannedStudySite; StudySite
Facility
... note
No BRIDG mapping
  • .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN
  • type=ST]
... classifier
... associatedParty
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... name
.... role
.... period
.... classifier
.... party
... progressStatus
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... state
.... actual
.... period
... whyStopped
FiveWs.why[x]
StudyOverallStatus.studyStoppedReasonCode
Why Study Stopped
... recruitment
FiveWs.subject[x]
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)
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... targetNumber
.... actualNumber
.... eligibility
.... actualGroup
FiveWs.subject[x]
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)
... comparisonGroup
Arm
Arms
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... targetNumber
.... actualNumber
.... eligibility
.... observedGroup
... 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
.... description
.... outcomeMeasure
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... name
..... type
..... description
..... endpoint
..... population
..... intervention
..... comparator
..... summaryMeasure
..... eventHandling
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... event
...... group
...... handling
...... description
... result

doco Documentation for this format