CDISC is Proud to Announce a Research Collaboration to Incorporate FDA Business Rules into CDISC’s Open Rules Engine (CORE)

Austin, TX – January 16, 2024 – CDISC is proud to announce a research collaboration with the U.S. Food and Drug Administration’s Office of Translational Sciences in the Center for Drug Evaluation and Research and Office of Regulatory Operations in the Center for Biologics Evaluation and Research to incorporate FDA Business Rules into CDISC’s Open Rules Engine (CORE).

CDISC’s CORE project provides an open-source version of the CDISC Conformance Rules in a machine-executable format. These rules, published and managed by CDISC, create a single source for conformance rules and allow external vendors and sponsor companies to implement and extend these rules within their tools. FDA Business Rules are currently written in a plain text, non-machine executable format and describe the business requirements for regulatory review to help ensure that clinical trial study data is compliant and useful and supports meaningful review and analysis. 

The goal of this effort, which began on November 3, 2023 and has term of three (3) years, is to collaborate on providing input on machine-executable formats of the FDA Business Rules and on the development and ongoing governance of this set of executable rules within CORE that can be used by sponsors of medical product applications. 

“CDISC is grateful for the opportunity to partner with CDER and CBER to establish a single source for machine-executable Conformance Rules and drive the implementation by the industry,” said Peter Van Reusel, Chief Standards Officer at CDISC.

The benefits of creating a single comprehensive and credible source of validation rules include increasing access, transparency, and visibility of validation rules used to ensure the quality and usability of study data in FDA. This will enable sponsors to submit high quality study data that will be ready for regulatory review saving time and effort for all parties involved.

“Our research collaboration with CDISC is an important step to ensure that study data validation rules are understandable and accessible to all,” said Lilliam Rosario, Ph.D., Director, Office of Computational Science, Office of Translational Sciences, CDER.


Melissa Kirwin