CDISC invites you to submit comments on the draft v4.0 of the Unified Study Definitions Model (USDM) during the 30-day Public Review period.
CDISC, in continued collaboration with TransCelerate’s Digital Data Flow Project, is updating the reference architecture, which will serve as a standard model for the development of a Study Definitions Repository. The Repository is a novel central component aimed at facilitating the exchange of structured study definitions across clinical systems using technical and data standards.
The focus of Phase 4 is:
- More focus on refinement rather than new content with development in the following areas
- Notes & Criteria
- Activity Groups
- Multiple Template Support (M11 alignment)
- Abbreviations
- Interventions, Identifiers & Roles (M11 alignment)
- Amendments (M11 alignment)
- Estimands (M11 alignment)
- Observational & Device Studies
- Final M11 alignment
- Attention to backward compatibility
- Maximum alignment with ICH M11
- Conformance Rule Specification Development
Deliverables include a logical data model, supporting Controlled Terminology, API specifications, Conformance Rule Specifications and an associated Implementation Guide.
To Provide Comments:
- An information page on the draft USDM v4.0 for public review can be here. DDF Phase 4 Public Review Dashboard.
- Reviewers are requested to provide comments via JIRA. Detailed instructions on reviewing the document and using the Wiki and JIRA can also be found on this page. DDF Phase 4 Public Review Dashboard
- Public Review closes 3 April 2025
You will need to log in or register for the CDISC Wiki to provide comments.
- Register for the Wiki. If you already have an account on Wiki or JIRA, our issue-tracking system, simply log in to your account; Wiki and JIRA use the same login credentials. CDISC Wiki is a different login from www.cdisc.org.
Public Review Workshops:
- CDISC conducted an initial Public Review workshop in Tuesday . The recording and presentation materials are available on the DDF Phase 4 Public Review Dashboard.
- CDISC is conducting two additional Public Review workshops:
- Tuesday 11:00-12:00 US Eastern
- Tuesday 11:00-12:00 US Eastern
- These coincide with the DDF SME Meeting times. If you are not part of the SME group and want to join these workshops please contact John Owen (jowen@cdisc.org)
Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.
Thank you for contributing your time and expertise.