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CDISC Lab Semantics in FHIR (PSS in Confluence)

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Basics

CDISC Lab Semantics in FHIR (PSS in Confluence)

1425
Ballot - STU to Normative


FHIR Implementation Guide

Implementation Guide

Details

Biomedical Research and Regulation (BRR WG) and Transcelerate Biopharma (TCB)are assessing the use of FHIR resources to exchange clinical trial lab data. The Clinical Data Interchange Standards Consortium (CDISC) Lab Model and LB domain standards currently contain the semantics that are used in Lab data exchange. These standards will be mapped to FHIR, and gaps will be identified. This project is expected to deliver a mapping spreadsheet, Clinical Research Lab Profile with needed extensions, and an Implementation Guide. These deliverables will be universal.


Clinical trials routinely exchange lab data between labs, contract research organizations, and trial sponsor companies. The project will provide another implementation option of the CDISC standards.



Mapping Spreadsheet Complete, candidate extensions identified - Target: 31 May 2018 Test at Connectathon - Target: September 2018 Extensions and profiles created - Target: May 2019 Implementation Guide Draft Published - Target: September 2019 Project End Date (all objectives have been met) - Target: October 2019


http://confluence.hl7.org/display/BRR/CDISC+Lab+Semantics+-+FHIR+Investigation+and+Implementation+Guide

Transcelerate Biopharma

N/A

Clinical and Public Health Laboratories, Regulatory Agency,Pharmaceutical

1) Transcelerate Biopharma 2) Lilly

The TCB team would like to test the deliverables at the September 2018 Connectathon.

CDISC Lab Model Project

N/A

Yes

N/A

No

2025 August: TSC approved an STU extension request for STU Extension Request for Clinical Research Sponsor Laboratory Semantics in FHIR Implementation Guide v1.0.0 - STU 1 for 2 years 2023 May: JDuteau: BRR will submit an STU Extension request 2020 June: TSC Approved STU Publication Request for CDISC Lab Semantics in FHIR for 2 years 2018 Sept: HGlover: CSD review requested changes in the PSS; after the WG makes those changes, the PSS will be brought back to the CSD for review For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? FHIR R4
Organization & Realm

Universal

People

Julie Evans,Hugh Glover



Biomedical Research and Regulation Work Group

Orders and Observations Work Group

Status & Dates

Active

STU - Test Period/Accepting Comments

05/31/2018

09/01/2027

2027 Sept WGM/Ballot

09/01/2027

2027 Sept WGM/Ballot

2019 Sept Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 0 Negatives to reconcile Document Name: HL7 FHIR® Implementation Guide: CDISC Lab Semantics, Release 1 2018 Oct Ballot Cycle Info: COMMENT ONLY Ballot results: Postponed Document Name: HL7 FHIR Implementation Guide: CDISC Lab Semantics, Release 1 FMG feedback: Needs OO as cosponsor; needs to ballot STU prior to publication.
Approvals

02/18/2019


Not Needed


All Received




System Info



View Ballot Items (with NIBs)




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