CDISC Lab Semantics in FHIR Implementation Guide (Release 0.1.0 STU 1 Ballot 1)

This page is part of the CDISC Lab Semantics in FHIR (v0.1.0: STU1 Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

Downloads

Package File

The following package file contains an NPM Package used by many of the FHIR tools.

 

Documentation

A narrative, FHIR resource domain model, and FHIR to CDISC data mappings are provided to assist in transforming laboratory data in FHIR format to a CDISC-compliant structures and standards.

 

Use Case 1: FHIR to CDISC LAB XML

For the September 2018 Connectathon, transformation code was written to query a sandbox FHIR server and convert the resulting FHIR file into the CDISC LAB XML standard format. The code is written in Java and is available in github. The FHIR to CDISC data mapping contains the path information that was used in the Java code. Connectathon Code for Lab IG A sample data set has been developed to provide example data for testing.

Download the sample data spreadsheet here.

Clinical Research Laboratory Data Narrative

Narratives, also known as scenarios, provide insight and context around the domain being discussed. By walking the reader through a fictitious example, the narrative highlights concepts important for the mapping and modeling work, and provides details for the creation of the test data set.

Lab Narrative

Clinical Research Laboratory Domain Model

The domain model provides a graphic representation of the relevant FHIR resources, attributes, and associations.

Domain Model

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

 

Use Case 2: FHIR to CDISC CDASH or SDTM

Since implementations of CDASH and SDTM data stores may vary by sponsor, please see the FHIR to CDISC data mapping document for field level equivalencies to use in processing FHIR lab data files.

Data Mapping: LAB_LB_FHIR_mapping_and_gaps_for_IG.xlsx

 

IG Download

Download the entire implementation guide here.