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 BioPharma Inc.’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: https://lnkd.in/edidEDHC 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. 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?04 Mar 2025. The recording and presentation materials are available on the?DDF Phase 4 Public Review Dashboard. CDISC is conducting two additional Public Review workshops: ? Tuesday?18 Mar 2025?11:00-12:00 US Eastern ? Tuesday?25 Mar 2025?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. 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. #cleardataclearimpact
