CDISC has launched a project that will facilitate the use of electronic health record (EHR) data in clinical research to achieve efficiencies that expedite global regulatory reviews, contribute to the evaluation of new treatments for patients and drive next generation discovery.
The FHIR to CDISC 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 datasets.
CDISC has engaged the consulting firm, Gevity Consulting Inc. (Gevity), to carry out project scoping and development. Gevity’s Lloyd McKenzie, one of the initial developers of the FHIR standard, will spearhead the effort. CDISC and Gevity will work together 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 single, trusted, authoritative source of CDISC standards metadata.
“Facilitating the development of quality tools to help unlock the benefits of standardization is an essential component of CDISC’s Strategic Plan,” stated David R. Bobbitt, CDISC President and CEO. “We look forward to providing our community with the knowledge and tools they need to support good science.”
“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, Vice President, Development Opportunities. “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.”
Mr. McKenzie, a senior consultant with Gevity, agreed. “When HL7 first created FHIR, it was with the intention that it could be used by anyone, including other standards development organizations. Making it easier for the research community to access data, while still abiding by data access controls such as patient consent has always been one of my personal objectives for FHIR. It’s great to see this project helping to make that a reality.”
CDISC will leverage existing work from our EHR to CDASH project, which developed mappings to enable the transfer of healthcare data into a form for data collection in clinical research. We anticipate to release the mapping and Implementation Guide in 2021.
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 and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. www.cdisc.org.
Gevity Consulting offers professional services to clients seeking to establish sustainable and effective healthcare, life sciences and social services systems. From strategic planning and advisory services to supporting and implementing critical transformation initiatives, we work with healthcare organizations to deliver results and enable a healthier world. We have been in business since 1995 and have grown steadily through geographic and service portfolio expansion. For more information, please visit www.gevityinc.com.