Clinical research standards organization CDISC has launched a project that will facilitate the use of EHR data in clinical research to expedite global regulatory reviews, contribute to the evaluation of new treatments for patients and drive next-generation discovery.
The project will leverage Fast Healthcare Interoperability Resources (FHIR), HL7’s standard for exchanging healthcare information electronically and CDISC’s standards for data collection (CDASH) and data tabulation (SDTM) to streamline the flow of data from EHRs to CDISC submission-ready data sets.
The nonprofit CDISC and Gevity Consulting Inc.’s Lloyd McKenzie will work to develop a dynamic mapping of FHIR resources and an Implementation Guide that will be made exclusively available to CDISC member organizations. The mapping and Implementation Guide will eventually be available via the CDISC Library API, the authoritative source of CDISC standards metadata.
“As EHRs and other real-world data sources play an increasingly important role in clinical research and healthcare decision making, our FHIR-to-CDISC project is timelier than ever,” said Rhonda Facile, CDISC vice president, development opportunities, in a statement. “The project will foster greater efficiencies across systems and resources, and encourage end users to support higher quality data exchange integrations within, and outside of, research.”
CDISC will leverage existing work from its EHR-to-CDASH project, which developed mappings to enable the transfer of healthcare data into a form for data collection in clinical research. It anticipates releasing the mapping and Implementation Guide in 2021.