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. This new CDISC Engine can run from the desktop GUI or command-line interface (CLI) on any platform in which you have already installed P21 Community.
As announced on June 1st 2021, CDISC has initiated the CDISC CORE project to develop:
As a longtime supporter of uniform standards for study data, P21 has actively contributed to the development of CORE. P21 has lent our subject matter expertise to various sub-teams and our software engineering talent to the CORE Software Engineering DEV team.
P21 is now the first vendor to extend upon CORE’s reference implementation, with instant delivery to tens of thousands of users. Our goals are to:
Caution: The CORE Engine is an experimental, in-development Engine. Validations run with this Engine include an advisory message in the results.
To try out this Engine, upgrade to P21C 4.0 and then run the Validator:
java -jar p21-client-1.0.5.jar --source.sdtm="DM.xpt" --engine.version="CDISC 0000.1" --standard=sdtm --standard.version=3.4 --report=cdisc-report.xlsx
For the CORE Engine, each Conformance Rule is represented by a separate YML file inside the “rules” directory. During validation, all YML files that are in this directory are picked up and executed against your datasets. To add or edit an existing rule:
We look forward to engaging and serving the broader community as the CORE Conformance Rules mature, and working with our clients at the US FDA, Japan’s PMDA, etc. as these Rules move towards final publication. We appreciate the effort invested by the many contributors in improving validation solutions in this way!
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