Mappings for the Profile.
| CRCoreResearchStudy |
| ResearchStudy | ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion |
| identifier | 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 |
| 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 |
| CRCoreResearchStudy |
| ResearchStudy | Entity. Role, or Act |
| text | Act.text? |
| contained | N/A |
| extension | N/A |
| modifierExtension | N/A |
| identifier | .identifier |
| id | n/a |
| extension | n/a |
| use | Role.code or implied by context |
| type | Role.code or implied by context |
| system | II.root or Role.id.root |
| value | II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) |
| period | Role.effectiveTime or implied by context |
| assigner | II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper |
| protocol | .outboundRelationship[typeCode=DEFN].target |
| partOf | .inboundRelationship[typeCode=COMP].source[moodCode=EVN] |
| status | .status |
| enrollment | .participation[typeCode=SBJ].role |
| period | .effectiveTime |
| sponsor | .participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE] |
| note | .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST] |
| arm | |
| id | n/a |
| extension | n/a |
| modifierExtension | N/A |
| objective | |
| id | n/a |
| extension | n/a |
| modifierExtension | N/A |
| CRCoreResearchStudy |
| ResearchStudy | |
| identifier | 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 |
| 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 |
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