Section 1c: FHIR®

HL7 FHIR® Implementation Guide: FHIR to CDISC Joint Mappings, Release 1

DESCRIPTION

This implementation guide, a joint effort of CDISC and HL7, defines mappings between FHIR release 4.0 and three specific CDISC standards: SDTM, CDASH and LAB.

ALTERNATIVE NAMES

HL7 FHIR® Implementation Guide: FHIR to CDISC Joint Mappings, Release 1 may also go by the following names or acronyms:

"HL7 FHIR® IG: FHIR to CDISC, R1", CDISC CDASH, CDASH

BENEFITS

By making it easier to convert data between HL7 FHIR (commonly used in clinical systems to collect and share healthcare data) and CDISC standards (commonly used to submit clinical trial data for analysis and regulatory approval), both organizations aim to reduce the barriers to using clinical information to support research.

Possible uses include:

  • Capturing 'real world evidence' (RWE) where clinical data not directly captured for clinical trial purposes can be used to support regulatory applications.
  • Allowing trial-driven data capture to occur directly inside clinical systems rather than separate clinical trial management solutions, leveraging technologies like SMART on FHIR. This is sometimes referred to as e-sourced data.
  • Making it easier to leverage clinical data in retrospective studies.
  • Supporting the creation of case report forms (CRFs) that link to data elements defined using FHIR resources and profiles.
  • Enabling experts from both standards communities to understand each others terms and better align both sets of specifications as they continue to evolve.

IMPLEMENTATIONS/CASE STUDIES

N/A - This guide defines how to map concepts, it is not implemented directly

DEVELOPMENT BACKGROUND

This specification was jointly balloted by both CDISC and HL7. It covers a subset of the SDTM and CDASH domains. The mappings are specific to particular versions of the respective organizations' standards. Future releases may encompass additional domains and/or newer releases.

RELATED DOCUMENTS

HL7 FHIR® Implementation Guide: FHIR to CDISC Joint Mappings, Release 1

STU DOCUMENTS

HL7 FHIR® Implementation Guide: FHIR to CDISC Joint Mappings, Release 1 See the standard at http://hl7.org/fhir/uv/cdisc-mapping/STU1. Expiration Aug 2023

TOPIC

  • Regulated Studies

BALLOT TYPE

  • STU

STATUS DATE

2021-08-31

RESPONSIBLE WORK GROUP

Biomedical Research and Regulation

PRODUCT TYPE

  • Implementation Guide

STAKEHOLDERS

  • Clinical and Public Health Laboratories
  • Clinical Decision Support Systems Vendors
  • EHR, PHR Vendors
  • Health Care IT Vendors
  • Healthcare Institutions
  • HIS Vendors
  • Lab Vendors
  • Pharmaceutical Vendors
  • Regulatory Agency
  • Standards Development Organizations (SDOs)

FAMILY

  • FHIR

CURRENT STATE

  • Active

REALM

  • Universal