Digital Data Flow Project Phase 2 Public Review


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
Language: English
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