-
After the successful release of USDM v3.0 in April 2024, CDISC continues the collaboration with TransCelerate’s Digital Data Flow Project into Phase 4. This phase will focus on further enhancement to the Unified Study Definition (USDM) 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 areas of DDF Phase 4 are:
- USDM Enhancements including further IDMP Alignment, refinement of amendments and versions to align with ICH-M11, complex studies designs such as multiphase seamless designs, additional trial registration mappings, and statistical/estimands enhancements
- Continued alignment of USDM with the emerging ICH M11 template and technical specification
- Participation in the Utilizing the Digital Protocol (UDP) project with TransCelerate, ICH and HL7 Vulcan
- Continued development of USDM Conformance Rules to support USDM v3.0 and v4.0
- Continued support and development of test data and test tools
- Development of training and education materials in conjunction with TransCelerate’s Change and Engagement team to foster adoption of DDF
- Alignment on study design elements with CDISC's Trial Master File (TMF) reference model
Join us for this informational webinar to learn about the release of Phase 3 and additional details on Phase 4 of this exciting project.
Presenters
- John Owen, CDISC
- Dave Iberson-Hurst, CDISC
- Berber Snoeijer, CDISC
- Bill Illis, DDF Workstream Initiative Lead
System Requirements: Click here to ensure your machine has the necessary requirements to run CDISC webinars (Zoom).