Background
P21 is proud to announce that support for CDISC Open Rules Engine (CORE) is now available in P21 Community 4.0. We have expanded CORE’s reference implementation to let you execute machine-readable CDISC Conformance Rules within the familiar P21 toolkit on any platform in which you have already installed P21 Community.
Use with Caution
However, bear in mind this advisory: The CDISC Engine, aka “CORE,” is an experimental, in-development Engine. Validations run with this Engine include an advisory message in the results, to emphasize that:
The CORE Engine has a limited Rule set and thus cannot detect most data Issues. Expect "false negatives," meaning, your datasets will deceptively appear to have fewer Issues than they actually do.
More important, because no regulatory agency uses the CORE Engine, you should instead always use a valid production-grade Engine (FDA, PMDA, etc.) for actual submissions of real study data.
Read more about this context and intended use on our blog: Pinnacle 21 Adds Support for CDISC Open Rules Engine (CORE).
