Clinical Research Sponsor Laboratory Semantics in FHIR Implementation Guide (Release 1.0.0)

This page is part of the CDISC Lab Semantics in FHIR (v1.0.0: STU1) based on FHIR R4. This is the current published version in it's permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Mappings and Profiles

FHIR to CDISC Laboratory Data Mapping

The FHIR to CDISC mapping is useful for understanding how to relate FHIR resources and attributes to CDISC-compliant data structures and standards. To ensure a more comprehensive solution, FHIR resources are compared (mapped) to three existing CDISC standards that are used in clinical research laboratory data exchange: the CDISC LAB model, CDASH LB Domain variables, and SDTM LB variables.

Data Mapping: LAB_LB_FHIR_mapping_and_gaps_for_IG.xlsx


Profiles

No profiles are applicable for this implementation guide.


Extensions

  • Observation: Observation to ResearchStudy linkage (workflow-researchStudy) associates lab results with a particular study Observation to ResearchStudy
  • Specimen: Cqf-relativeDateTime captures the collection relative to an event, such as administration of medication Relative Collection
  • Race: Patient race (us-core-race) Race