Background
To address the challenge of communicating across varying standards, the BR&R team partnered with TransCelerate clinical research sponsor organizations to understand the various standards for recording and submitting laboratory data. Through this partnership, mappings were developed between the FHIR standard that is emerging in research, and the CDISC standards currently being used. The work was documented in an implementation guide.
The current version of the implementation guide, which was included in the September 2019 ballot process, is located at:
Clinical Research Sponsor Laboratory Semantics in FHIR (hl7.org)
Please note that, prior to ballot, the FHIR team requested that the name be changed from the original title (CDISC Lab Semantics in FHIR) to remove CDISC from the title and focus on the use case. The title was changed from CDISC Laboratory Semantics to Clinical Research Sponsor Laboratory Semantics to accommodate that request.
Since that time, the mappings (LAB and LB) have been incorporated into another Implementation Guide - the FHIR to CDISC Joint Mapping Implementation Guide located at: HL7.FHIR.UV.CDISC-MAPPING\IG Home Page - FHIR v4.0.1. Since this was a mapping IG, the content in the Lab IG that pertains to process flow is still relevant and the IG is still in an active state.
Future Plans:
In 2022, TransCelerate was planning to partner with the Society for Clinical Data Management (SCDM) to benchmark and pilot data exchanges for laboratory data. Unfortunately, that project was cancelled. This IG may be a candidate for the Vulcan Real World data initiative. Since the mappings have been migrated to the FHIR to CDISC Joint Mapping IG, they should be removed from the Lab IG.