Digital Therapeutic Area User Guides: A Modern Approach to Developing CDISC Standards

About this session

Part of Session 2: CDISC Plenary - 360i Vision & Roadmap (Chair: Julie Smiley, CDISC).

This presentation focuses on the evolution of CDISC Therapeutic Area User Guides (TAUGs) as part of the broader CDISC 360i vision for a fully digital, interoperable standards ecosystem. While TAUGs have successfully extended foundational standards into disease-specific contexts, they remain largely document-based and rely on interpretation across the data lifecycle limiting consistency, reuse, and automation.
We describe a shift to a “meaning-first” paradigm, where biomedical concepts serve as the core digital assets underpinning standards. By separating clinical meaning from implementation and making that meaning computable, these digital assets enable intent to flow seamlessly from protocol through analysis.
Using a real-world scenario, we demonstrate how future Digital TAUGs could support flexible, analysis-informed registry while lowering barriers to adoption. This approach lays the foundation for scalable reuse, machine-readability, and AI-enabled workflows.

Speaker

• BL

  Bess LeRoy

  CDISC

  Speaker