CDISC invites you to to submit comments on version 1.0 of the FHIR-to-CDISC Mapping during Public Review. FHIR-to-CDISC Mapping. v1.0 expands and improves upon mappings developed by the CDISC EHR-to-CDASH (E2C) team to achieve greater interoperability and exchange of data from Electronic Health Records (EHRs) to clinical research submission-ready datasets. The FHIR-to-CDISC mappings (encompassing FHIR R4, LAB v 1.0, CDASHIG v 2.1, and SDTMIG 3.2 standards) target LAB and six core CDASH and SDTM domains (i.e., AE, CM, DM, MH, PR, and VS). The mappings will be jointly balloted by CDISC and HL7 using their respective governance processes. All publication material will be made freely accessible for use and cross-referenced between HL7 and CDISC, where necessary.
The official authoritative FHIR-to-CDISC mappings will be published as:
- HL7 CDISC FHIR IG
- Mappings (as Excel and XML)
- CDISC Library
Focus Domains include:
- Adverse Events
- Adverse Events Medications
- Concomitant Medications
- Medical History
- Vital Signs
- Laboratory Test Results
To Provide Comments
- View the draft: FHIR-to-CDISC Mapping
- View Read Me file with further information about the mapping: Read Me for Review of FHIR Mapping Spreadsheet
- Instructions for providing comments: Instructions for Reviewers.
You will need to log in or register for the CDISC Wiki to provide comments.
- Register for the Wiki. If you already have an account on Wiki or JIRA, our issue-tracking system, simply log in to your account; Wiki and JIRA use the same login credentials. CDISC Wiki is a different login from www.cdisc.org.
Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.
Thank you for contributing your time and expertise.