Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## Resource Profile: M11 Research Study Profile - Mappings

Page standards status: Trial-use | Maturity Level: 2

Mappings for the m11-research-study-profile resource profile.

#### Mappings to Structures in this Implementation Guide

No Mappings Found

#### Mappings to other Structures

No Mappings Found

#### Other Mappings

Name | FiveWs Pattern Mapping | BRIDG 5.1 Mapping | HL7 V2 Mapping | RIM Mapping | ClinicalTrials.gov Mapping
--- | --- | --- | --- | --- | ---
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:narrative |  |  |  |  |
extension:amendment |  |  |  |  |
extension:confidentialityStatement |  |  |  |  |
extension:approval |  |  |  |  |
extension:m11-research-study |  |  |  |  |
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
id |  |  |  | n/a |
extension |  |  |  | n/a |
use |  |  | N/A | Role.code or implied by context |
type |  |  | CX.5 | Role.code or implied by context |
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 |
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 |
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 |  |  |  |  |
id |  |  |  | n/a |
extension |  |  |  | n/a |
reference |  |  |  | N/A |
type |  |  |  | N/A |
identifier |  |  |  | .identifier |
display |  |  |  | N/A |
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 |  |  |  |  |
Documentation for this format