CCDISC standards have become the foundation for clinical research standards used globally by pharmaceutical companies, leveraged by technology vendors, and required by major regulatory agencies. Over the last 25 years, CDISC has developed the largest and most robust library of clinical trial content and terminology used to design and execute clinical trials.However, over that same time we have created challenges with the way we have implemented the standards that limits our ability to realize the full benefits due to the gaps on connecting the standards. Today, the content in the standards is siloed from study design through data collection and finally the analysis and it requires a person to translate the content between the different standards. The need to have subject matter experts to support this translation creates a steep learning curve for adoption and does not fully enable today’s technology. CDISC has put forward a vision and roadmap to shift our standards from siloed models to end to end connected standards adding metadata to provide the context required to enable machines and reduce the manual expertise currently required to implement standards. Transforming to this end to end mindset will help create ready to use standards that are interoperable and easy to adopt by all stakeholders.

This presentation will provide an overview of the CDISC vision and roadmap as well as specific activities within the roadmap that will initiate in 2025 to realize this transformation. As part of that CDISC roadmap we will provide a more in depth overview of recent digital protocol initiatives whose goal is to move from a document-centric to a Data-centric Protocol that will enable AI, Drive Automation, and Design Better Trials.