CDISC LAB Model FHIR IG Proposal

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CDISC LAB Model

Owning work group name

BR&R

Committee Approval Date:

Please enter the date that the committee approved this IGproposal

Contributing or Reviewing Work Groups

None

FHIR Development Project Insight ID

1425

Scope of coverage

Clinical trials routinely exchange lab data between labs, contract research organizations, and trial sponsor companies. On the clinical research side the required format is the CDISC LAB or LB format. The IG will show how data from Labs in FHIR format can be converted into the required CDISC format.

IG Purpose

Without an IG the mapping from FHIR to the CDISC format is likely to be inconsistent.

Content location

https://github.com/HL7/cdisc_lab


Proposed IG realm and code

uv/cdisc-lab

Maintenance Plan

Current resources are committed to completion of the initial publication. Thereafter the WG expects to maintain this IG from an administrative perspective and for minor revisions. Any major revision will depend on appropriate provision of resource, but this is very likely to be forthcoming.

Short Description

The IG shows how laboratory data in FHIR format can be converted into the CDISC LAB or LB format.


Long Description

Clinical trials routinely exchange lab data between labs, contract research organizations, and trial sponsor companies. On the clinical research side the required format is the CDISC LAB or LB format. The IG shows how laboratory data in FHIR format can be converted into the CDISC LAB or LB format.


Involved parties

Created by a collaboration between HL7 BR&R and Transcellerate Biopharma


Expected implementations

Transcellerate Biopharma has prioritised this as a requirement for their member bodies. Lilly already have working code following this guide.

Content sources

CDISC LAB and LB

Example Scenarios

1. Laboratory provides results in FHIR format - Clinical Trial software converts results to CDISC LAB format and add to data submission for analysis by sponsor

This is probably the only scenario since the CDISC standards are only of use in Clinical Trials

IG Relationships

None

Timelines

May 2019

When IG Proposal Is Complete

When you have completed your proposal, please send an email to FMGcontact@HL7.org

FMG Notes

Copyright © Health Level Seven International ® ALL RIGHTS RESERVED. The reproduction of this material in any form is strictly forbidden without the written permission of the publisher.