In continued collaboration with TransCelerate’s Digital Data Flow Project, CDISC has moved into Phase 3 of the Digital Data Flow (DDF) project, following the release of the USDM v2.0 in July 2023. DDF Phase 3 will focus on updating 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 of DDF Phase 3 is:
· Digitization of all protocol elements in alignment with the ICH M11 Technical Specification, capturing the full breadth of M11 template components completely, followed by greater depth of some structured content within the model (e.g., structured I/E criteria, objectives, and endpoints).
· Expansion of the population of SDTM Trial Design domains from the USDM model, including potential new trial design artifacts from M11.
· Enabling the use of the USDM to populate components required for Global Trial Registry Reporting.
Join us for this informational webinar for Phase 3 of this project where we will present more details on the areas of focus for this new and exciting phase of the USDM development.
- John Owen (CDISC DDF Project Manager)
- Dave Iberson-Hurst (CDISC DDF Product Owner)
- Berber Snoeijer (CDISC DDF Technical Lead)