Clinical Study Schedule of Activities, published by HL7 International - Biomedical Research & Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/Vulcan-schedule-ig/ and changes regularly. See the Directory of published versions
Mappings for the ResearchStudySoa resource profile.
| ResearchStudySoa |
| 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 |
| ResearchStudySoa |
| 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 |
|
Propose a change