Skip to end of metadata
Go to start of metadata

Background

The FDA mandates that clinical trial data used to support approval of drugs and devices is submitted using CDISC standards. However, much of the research is conducted using clinical systems where data is typically exposed and shared as FHIR. Having standardized mappings for converting that clinical data for research use will save significant time on redundant data entry, independent mapping exercises and conversion issues.

Scope

The overarching goal of this project is to improve interoperability, and facilitate the exchange of data from EHRs to clinical research submission-ready datasets. Building upon previous work on the FDA eSource grant, the PHUSE Research on FHIR projects, and the CDMH project, CDISC will collaborate with HL7, TransCelerate BioPharma and other potential partners to complete the development of a fully SME reviewed/approved FHIR-to-CDISC (CDASH and SDTMIG 3.2) mappings for seven core domains (AE, CM, DM, MH, PR and VS). The mappings will be jointly balloted by CDISC and HL7 using their respective governance processes. Based on potential gaps identified through the mapping activities, CDISC standards may be enhanced/expanded. This will aid in either potentially eliminating and/or reducing such gaps that account for RWD digital sources (e.g., EHRs, ePROs, TeleHealth, etc.) and to improve interoperability.

The official authoritative FHIR-to-CDISC mappings will be published as: 1) FHIR IG and 2) CDISC Library (CDISC's MDR) as either HTML, JSON or XML media types. Both publication formats will be made freely accessible for use. Making the mappings available via the CDISC Library API permits software vendors to integrate within their systems and to use them to automate eSource and other such related activities. In addition, the mappings will include FHIR R5 draft mapping solutions and mitigation instructions to aid in future maintenance updates.

PSS Link:  FHIR to CDISC (CDASH, SDTMIG 3.2)


Project Status

FHIR Resources (Draft)

Below is the list of FHIR Resources that were referenced/mapped/used on this project:


  • No labels