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Difference between revisions of "CDISC LAB Model FHIR IG Proposal"

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==FHIR Development Project Insight ID==
 
==FHIR Development Project Insight ID==
 
+
[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1425 1425]
 
<!-- Please specify the id of your work group’s PSS for doing FHIR work that covers the development and maintenance of this IG.  (If submitted but not yet approved, just write “pending”.) The link to the PSS template can be found here: http://gforge.hl7.org/gf/download/docmanfileversion/6832/9398/HL7FHIR_DSTUballotPSS-20120529.doc -->
 
<!-- Please specify the id of your work group’s PSS for doing FHIR work that covers the development and maintenance of this IG.  (If submitted but not yet approved, just write “pending”.) The link to the PSS template can be found here: http://gforge.hl7.org/gf/download/docmanfileversion/6832/9398/HL7FHIR_DSTUballotPSS-20120529.doc -->
  
 
==Scope of coverage==
 
==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.
 
<!-- Define the full scope of coverage for the IG.  The scope must be clearly delineated such that it does not overlap with any other existing or expected HL7 Int'l-maintained IG.  The scope will be used to govern "what is the set of potential applications to consider when evaluating what elements are 'core' – i.e. in the 80%"
 
<!-- Define the full scope of coverage for the IG.  The scope must be clearly delineated such that it does not overlap with any other existing or expected HL7 Int'l-maintained IG.  The scope will be used to govern "what is the set of potential applications to consider when evaluating what elements are 'core' – i.e. in the 80%"
  
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==IG Purpose==
 
==IG Purpose==
 
+
Without an IG the mapping from FHIR to the CDISC format is likely to be inconsistent.
 
<!-- Why is this IG necessary? -->
 
<!-- Why is this IG necessary? -->
  
 
==Content location==
 
==Content location==
 
+
https://github.com/HL7/cdisc_lab
 
<!-- What is the path within the HL7 github repository (i.e. https://github.com/HL7/xxx) or what is the Simplifier project name? -->
 
<!-- What is the path within the HL7 github repository (i.e. https://github.com/HL7/xxx) or what is the Simplifier project name? -->
  
  
 
==Proposed IG realm and code==
 
==Proposed IG realm and code==
 
+
uv/cdisc_lab
 
<!-- What is the realm code (2-character country code or 'uv') and IG code to use for the path when the IG is published under http://hl7.org/fhir?  E.g. us/ccda -->
 
<!-- What is the realm code (2-character country code or 'uv') and IG code to use for the path when the IG is published under http://hl7.org/fhir?  E.g. us/ccda -->
  
 
==Maintenance Plan==
 
==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.
 
<!-- What commitment does the WG have to maintaining this IG as the FHIR core specification continues to evolve - particularly if the initial project sponsors are no longer providing resources -->
 
<!-- What commitment does the WG have to maintaining this IG as the FHIR core specification continues to evolve - particularly if the initial project sponsors are no longer providing resources -->
  
 
==Short Description==
 
==Short Description==
 
+
The IG shows how laboratory data in FHIR format can be converted into the CDISC LAB or LB format.
 
<!-- 1-2 sentences describing the purpose/scope of the IG for inclusion in the registry -->
 
<!-- 1-2 sentences describing the purpose/scope of the IG for inclusion in the registry -->
  
  
 
==Long Description==
 
==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.
 
<!-- 1 paragraph describing the purpose/scope of the IG in more detail for inclusion in the version history -->
 
<!-- 1 paragraph describing the purpose/scope of the IG in more detail for inclusion in the version history -->
  
  
 
==Involved parties==
 
==Involved parties==
 
+
Created by a collaboration between HL7 BR&R and Transcellerate Biopharma
 
<!-- 1 paragraph describing who is sponsoring or involved in creating the IG for inclusion in the version history -->
 
<!-- 1 paragraph describing who is sponsoring or involved in creating the IG for inclusion in the version history -->
  
  
 
==Expected implementations==
 
==Expected implementations==
 
+
Transcellerate Biopharma has prioritised this as a requirement for their member bodies.  Lilly already have working code following this guide.
 
<!--Key resources are justified by CCDA, for resources not deemed "key", what interest is there by implementers in using this particular resource. Provide named implementations if possible - ideally provide multiple independent implementations. -->
 
<!--Key resources are justified by CCDA, for resources not deemed "key", what interest is there by implementers in using this particular resource. Provide named implementations if possible - ideally provide multiple independent implementations. -->
  
 
==Content sources==
 
==Content sources==
 
+
[https://www.cdisc.org/standards/data-exchange/lab CDISC LAB and LB]
 
<!-- List all of the specifications (beyond those in the "standard" (FHIR_Design_Requirements_Sources) list of source specifications) that you’re planning to consult
 
<!-- List all of the specifications (beyond those in the "standard" (FHIR_Design_Requirements_Sources) list of source specifications) that you’re planning to consult
  
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==IG Relationships==
 
==IG Relationships==
 
+
None
 
<!-- Are there any IGs this resource depends on or that depend on this IG? -->
 
<!-- Are there any IGs this resource depends on or that depend on this IG? -->
  
 
==Timelines==
 
==Timelines==
 
+
May 2019
 
<!-- Indicate the target date for having the IGcomplete from a committee perspective and ready for vetting and voting -->
 
<!-- Indicate the target date for having the IGcomplete from a committee perspective and ready for vetting and voting -->
  

Revision as of 12:58, 24 January 2019



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

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