Digital Data Flow Project Phase 3 Public Review

In the continued collaboration with TransCelerate’s Digital Data Flow Project, CDISC 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 3 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 3 is:

• Aligning the USDM to the ICH M11 draft template on Clinical electronic Structured Harmonised Protocol (CeSHarP)
• Enabling additional SDTM Trial Design Population from the USDM
• Initial mapping to allow population of Clinical Trial Registry information from the USDM
• Enabling the model to handle more complex study designs including the complex cohorts
• General consistency enhancements to the USDM

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.