Clinical Study Schedule of Activities, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-snapshot built by the FHIR (HL7® FHIR® Standard) CI Build. 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

Changes

Page standards status: Informative

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Version = 2.0.0-snapshot

New Features and Model Updates:

• Updated profile requirements in research.fsh so version is now Must Support for relevant PlanDefinition-based profiles

Documentation and Navigation Improvements:

• Removed legacy ODM narrative page and replaced navigation references with USDM alignment content
• Added a new USDM Alignment page with mapping methodology from CDISC USDM to Vulcan SoA/FHIR artifacts
• Various typographical and reference updates

Technical and Packaging Updates:

• renamed primaryPurposeType to purposeType (R6-ballot5)

Version = 2.0.0-ballot

New Features and Model Updates:

• Expanded dynamic Schedule of Activities coverage based on implementer and ballot feedback
  • Added and clarified use cases for conditional activities
  • Expanded dynamic visit plan guidance for branching and complex transitions
  • Expanded unscheduled visit guidance
• Added and documented extension-driven dynamic semantics
  • soaTransition
  • soaTimepoint

Documentation and Navigation Improvements:

• Updated Home and dynamic pages to improve rationale, references, and terminology consistency
• Simplified Core Schedule of Activities Model narrative and corrected example naming/content
• Updated selected narrative text in Examples and Investigational Product Administration

Technical and Packaging Updates:

• Updated IG page/menu configuration and specification metadata to include USDM alignment and deprecate ODM content
• Corrected Requirements canonical URL in Requirements-fromNarrative.json
• Updated build and publisher helper scripts (Windows and shell variants) to improve argument handling, defaults, and offline/build behavior

Breaking Changes:

• Update Base FHIR R4 to FHIR R6

Version = 1.0

• Original Release