A2.2 Developing and Implementing CDISC CORE rules: from zero to hero

This presentation is part of a full breakout session. To add this presentation to your schedule you must add the full breakout session.

In clinical research, we have one mission: creating high quality data packages for statistical analysis, reporting, and ultimately submission to regulatory agencies. Volunteering in the CDISC CORE project, a free and open software allowing the entire clinical research industry to test their own study data packages on conformance to CDISC foundational standards as well as to regulatory requirements, is an exceptional opportunity to contribute to this. The enormous amount of conformance rules for SDTM, ADaM, and SEND makes this CDISC project a huge challenge. From project kick off with the volunteers in September 2021 until today, the CDISC CORE project evolved from basic concept into established validation system.

This presentation will share experiences of a volunteer in the CDISC CORE Rules Development team. Examples will demonstrate the rule editor functionality and illustrate how easy developing your own rules can be, even with a background as Data Manager and when lacking solid programming skills.

With CDISC CORE progressing further in the development phase, time has come to start implementation. Will we integrate the CDISC CORE engine in current systems or use it as a separate tool? And how about the company’s own specific rules?