– 01 Sep 2021 – CDISC and HL7 announced the release of the FHIR to CDISC Joint Mapping Implementation Guide, freely available on the CDISC and HL7 websites, to facilitate the use of electronic health record (EHR) data in clinical research. The Implementation Guide defines mappings between FHIR, HL7’s standard for exchanging healthcare information electronically and three CDISC Standards: CDASH (data collection), SDTM (data tabulation) and LAB (lab data exchange) to streamline the flow of data from EHRs to CDISC submission-ready datasets.
Converting data between FHIR and CDISC standards has the potential to foster greater efficiencies across systems and resources, while supporting semantic interoperability. This opens the door to leveraging real-world data where data are not directly captured for clinical trial purposes or for regulatory applications. The FHIR to CDISC Joint Mapping Implementation Guide also supports the creation of case report forms that link to data elements defined using FHIR resources and profiles with the CDISC variables embedded, enabling streamlined data collection time, reducing duplicative data-entry efforts, improving quality, and decreasing costs.
“This release is a significant milestone as CDISC and HL7 work together toward effectively linking healthcare and research while preserving the meaning and quality of the data,” said Rhonda Facile, Vice President, Partnerships and Development, CDISC. “CDISC has held a long-term vision of more efficient use of real-world data from EHRs as source data for research and augmenting clinical trial data to accelerate clinical research processes for the benefit of us all.”
Lloyd McKenzie, a senior consultant with Gevity and technical lead on the project added, “From the early days of FHIR, one of the things I’ve been most excited about is its ability to make data more easily available to the research space and to help close the loop in evaluating new therapies. This IG will help smooth the path to increased use of real-world data in research settings which will let us make better and faster decisions about what treatments are safe and effective.”
“I am pleased to see HL7 and CDISC, two of the most important standards organizations for clinical research, partnering to make data transfer more efficient. The collaborative nature of these two organizations will help to make the Vulcan Accelerator successful in its mission,” said Rob Goodwin, co-chair of the Vulcan HL7 FHIR ACCELERATOR™.
The Implementation Guide went through both the HL7 Balloting process and the CDISC Standards Development Process to ensure alignment and harmonization across the healthcare and clinical research communities.
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.