Release Date: 01 September 2021
Version 1.0 of the FHIR to CDISC Joint Mapping Implementation Guide defines mappings between FHIR release 4.0, HL7’s standard for exchanging healthcare information electronically and three CDISC Standards: CDASHIG v2.1, SDTMIG v3.2, and LAB v1.0.1 to streamline the flow of data from electronic health records (EHRs) to CDISC submission-ready datasets.
- FHIR to CDISC Mapping Implementation Guide - A spreadsheet of the FHIR to CDISC mappings with domain tabs and details from FHIR to CDASH to SDTM.
- FHIR to CDISC Mapping Implementation Guide Public Review Comments*
- FHIR to CDISC Mapping Implementation Guide in XML Format
Additional RWD Resources
- LOINC to LB Mapping File is an additional resource for capturing real-world data. Logical Observation Identifiers Names and Codes (LOINC®) terminology includes laboratory and clinical observations used in healthcare systems around the globe.
- Unit-UCUM Codetable provides mapping to toggle between UCUM and CDISC Units. Unified Code for Units of Measure (UCUM) contains a blueprint for the creation of compliant units of measure from more than 300 terminal unit symbols. UCUM is used in healthcare to populate electronic health records, such as laboratory records in LOINC, and in the ISO IDMP standard.
By making it easier to convert data between HL7 FHIR (commonly used in clinical systems to collect and share healthcare data) and CDISC standards, both organizations aim to reduce the barriers to using clinical information to support research.
HL7 FHIR Resources
In FHIR, implementation guides are a set of rules of how a particular interoperability or standards problem is solved through the use of FHIR resources. The FHIR to CDISC Joint Mapping Implementation Guide (IG) v1.0 is also posted to the HL7 website and provides the same content in a format similar to other FHIR implementation guides.
* CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.