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 detailing the findings, which will allow researchers to receive, process, and review study data more efficiently and effectively.
“We are excited to work with Microsoft on another important initiative that extends our current work in support of standards-based process automation,” said Sam Hume, CDISC VP, Data Science. “We look forward to building a community around CORE that will collaborate to create new innovative features and solutions.”
“Microsoft is pleased to expand our work with CDISC to build the next generation CDISC Open Source Rules Engine to support Pharma Industry’s digital transformation goals and ultimately accelerate time to market for life saving therapies.” –Patty Obermaier, VP of Health and Life Sciences, Microsoft US.
To support and grow a community of open-source software developers, CDISC has initiated the CDISC Open Source Alliance (COSA). Several CDISC member organizations as well as individual developers have already committed to participate in COSA. Microsoft will provide ongoing guidance. Once released, CORE will become a COSA project supported by a global team of open-source developers and CDISC. A key component of COSA is community development.
CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization with administrative offices in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. https://www.cdisc.org/