| ResearchStudy | |
| url | |
| identifier | Organization's Unique Protocol ID; Secondary IDs |
| version | |
| name | |
| title | Brief Title |
| label | |
| type | |
| value | |
| protocol | Interventions; Arm/Intervention Cross-Reference |
| partOf | |
| relatedArtifact | Citations, Links, Available Study Data/Documents |
| date | |
| status | |
| primaryPurposeType | |
| phase | Study Phase |
| studyDesign | Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention |
| focus | |
| condition | Conditions |
| keyword | Keywords |
| region | |
| descriptionSummary | |
| description | Detailed Description |
| period | Study Start Date (start); Study Completion Date (end) |
| site | Facility |
| note | |
| classifier | |
| associatedParty | |
| name | |
| role | |
| period | |
| classifier | |
| party | |
| progressStatus | |
| state | |
| actual | |
| period | |
| whyStopped | Why Study Stopped |
| recruitment | Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria) |
| targetNumber | |
| actualNumber | |
| eligibility | |
| actualGroup | Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria) |
| comparisonGroup | Arms |
| identifier | |
| name | Arm Label |
| type | Arm Type |
| description | Arm Description |
| intendedExposure | |
| observedGroup | |
| objective | |
| name | |
| type | |
| description | |
| outcomeMeasure | |
| name | |
| type | |
| description | |
| reference | |
| result | |
| ResearchStudy | ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion |
| url | |
| identifier | No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic) |
| version | |
| name | |
| title | No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study) |
| label | |
| type | |
| value | |
| protocol | StudyProtocolDocumentVersionPublicTitle.name |
| partOf | CompanionStudyRelationship |
| relatedArtifact | StudyProtocolDocument, StudyProtocolDocumentVersion |
| date | |
| status | StudyOverallStatus.code |
| primaryPurposeType | StudyProtocolVersion.primaryPurposeTypeCode |
| phase | StudyProtocolVersion.phaseCode |
| studyDesign | InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode |
| focus | |
| condition | StudyCondition.code |
| keyword | DocumentVersion.keywordCode; DocumentVersion.keywordText |
| region | StudyProtocolVersion.participatingLocationCode |
| descriptionSummary | |
| description | StudyProtocolDocumentVersion.publicDescription |
| period | ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration |
| site | PlannedStudySite; StudySite |
| note | No BRIDG mapping |
| classifier | |
| associatedParty | |
| name | |
| role | |
| period | |
| classifier | |
| party | |
| progressStatus | |
| state | |
| actual | |
| period | |
| whyStopped | StudyOverallStatus.studyStoppedReasonCode |
| recruitment | InterventionalStudyProtocol.interventionGroupQuantity |
| targetNumber | |
| actualNumber | |
| eligibility | |
| actualGroup | InterventionalStudyProtocol.interventionGroupQuantity |
| comparisonGroup | Arm |
| identifier | |
| name | Arm.name |
| type | Arm.typeCode |
| description | Arm.description |
| intendedExposure | |
| observedGroup | |
| objective | StudyObjective |
| name | No BRIDG mapping (BRIDG has a description, but not a name) |
| type | StudyObjective.typeCode |
| description | |
| outcomeMeasure | |
| name | |
| type | |
| description | |
| reference | |
| result | |
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