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We are proud to announce the release of CDISC CORE version 1.0. CORE, the open-source conformance rules engine for clinical trial data, is now production software for the whole community. Version 1.0 covers the complete SDTM and FDA Business Rules catalogs, while ADaM rules and Define-XML rules will be coming soon. CORE runs every rule at scale and is free for anyone to use.
In May 2025, CDISC joined forces with Verisian to turn CORE into production software for the whole community. The original implementation of CORE performed well for some rules and small studies. It struggled, however, with complicated rules and had limited scalability, which restricted its use in a production environment. The community needed an engine that was both reliable and scalable.
The refactoring had to meet three requirements. The general approach had to be preserved, so that existing work, including the contributions of CDISC and the community, could be reused. Support for custom rules developed to date had to be maintained, and those rules also had to scale. Above all, the result had to be production software that the largest pharmaceutical companies, regulatory authorities, and any other stakeholders could rely on.
CDISC and Verisian reviewed the existing architecture together and decided to replace the Pandas-based implementation with one based on SQL. Verisian assembled a dedicated team to work solely on this effort, and they refactored the engine over the months that followed. Since the fork of the original code base, the team has:
Alongside the engine, Verisian established a fully automated testing framework and new processes for rule development, testing, validation and quality assurance. These processes enable the community to contribute throughout the project and increase the transparency of any contribution.
Verisian took ownership of the technical implementation and testing and systematically protected the engine against regressions. This allowed the CDISC team to concentrate on the rules themselves: their definition and their usability. Each rule has its own suite of tests, co-developed by CDISC and Verisian, which is reviewed and validated continuously.
To support rule authoring and validation, Verisian created a contribution repository in which authors and contributors from CDISC and partners can write, test and ship new rules. Throughout, Verisian has continued to improve the engine, filling logic gaps that each new rule exposes.
This effort has required months of work from all stakeholders, and we are proud to have reached this v1.0 release that the whole community can rely on.
CORE v1.0 covers the complete SDTM and FDA Business Rules catalogs (500 SDTM rules and 183 FDA rules) and runs every one of them at scale on a refactored engine. Compared with the original implementation, it is 60 times faster on gigabyte-scale studies and can run a typical 2 GB study in about 10 minutes.
ADaM rules are next, 80% of which have already been written, followed by Define-XML rules. The longer-term ambition is full regulatory adoption, and CDISC, Verisian and other stakeholders will work with interested parties toward that goal. Sponsors across the industry are invited and encouraged to formally test CORE on their studies.
Verisian also offers a fully managed version of CORE, integrated with Verisian’s agentic platform for continuous validation with no limit on study submission size. Every finding can be traced to its source and reviewed alongside the exact code and data that triggered it, so conformance issues are addressed as they arise during development, and studies stay continuously validated and submission-ready. Organizations interested in this version are encouraged to get in touch.
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