CDISC Teams Up with Microsoft to Develop Open-Source Software for the Clinical Research Community
CDISC is teaming up with Microsoft to develop the CDISC Open Rules Engine (CORE), open-source software that executes machine-readable CDISC Conformance Rules. The global clinical research community will be able to leverage the CORE software to test study data for conformance to CDISC standards as well as regulatory and sponsor-specific conformance rule sets.
CDISC Conformance Rules as well as regulatory agency rules provide a critical quality check in ensuring study data conform to CDISC standards. An emerging industry best practice is to use Conformance Rules on an ongoing basis, throughout the study, to keep the data as close to submission ready as possible and to ensure quality in all data exchange scenarios. The free and open, Microsoft Azure-based CORE will execute Conformance Rules retrieved from the CDISC Library against standardized clinical research data and produce a report