CDISC, in the continued collaboration with TransCelerate’s Digital Data Flow Project, has updated 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.
Join us for the Public Review webinar for phase 2 of this project where we will:
- Introduce updates made to the Reference Architecture standards.
- Provide information on how to submit comments.
- Answer any questions you may have.
The focus of phase 2 is:
- Facilitating eCRF automation with the implementation of Biomedical Concepts into the model
- Enabling the model to handle more complex study designs including the representation of complex timing, branching and cycles.
- Adding protocol elements to help demonstrate population of structured USDM data elements to a protocol template.
Updated deliverables will include a logical data model, supporting Controlled Terminology, API specifications and a corresponding Implementation Guide. For more information, please visit the Digital Data Flow page.
Public Review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based standards are developed and adopted by a diverse global community interested in improving clinical research.
- John Owen, CDISC
- Dave Iberson-Hurst, CDISC
- TransCelerate Biopharma DDF Team