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Publication Request

Publication Request

1. Published Name of the Standard for which request is being made

Clinical Research Sponsor Laboratory Semantics in FHIR

2. Standards Material/Document

STU

3. Date of Request

Jun 10, 2020

4. Use Period

Two years

5. Reason for extension, timeline, and actions

6. Original Publication Date

7. End date of the current STU period

8. Length of the requested extension

9. Review Process

10. HL7 Work Group making this request and date

Biomedical Research and Regulation

10a. Requesting WG Date

Jun 10, 2020

11. URL of approval minutes

https://confluence.hl7.org/display/BRR/2020-06-09+Conference+Call

12. HL7 Product Management Group

FMG

12a. Management Group Date of Approval

Jun 24, 2020

13. URL of approval minutes

https://confluence.hl7.org/pages/viewpage.action?pageId=86969455&flashId=151289899

14. Is the artifact ready for final publication?

Yes

15. If not ready, please describe remaining steps.

N/A

16. Tool name used to produce the machine processable artifacts in the IG

org.hl7.fhir.publisher.jar

17. The name of the “IG artifact” within the context of the above mentioned tool.

Clinical Research Sponsor Laboratory Semantics in FHIR

18. Balloted Name of the standard for which request is being made

CDISC Lab Semantics in FHIR

19. Requested name for published standard

Clinical Research Sponsor Laboratory Semantics in FHIR

20. If CMET, list IDs balloted

N/A

21. Project Insight Number

1425

22. Document Realm

Global

23. Ballot cycle in which the document was successfully balloted

2019-SEP

24. Results of that ballot (following reconciliation activities):

24. Results of that ballot (following reconciliation activities):

(not needed for errata, STU extension, or unballoted STU update)

25. Affirmative

32

26. Negative

0

27. Abstentions

85

28. Not Returned

29. Total in ballot pool

117

30. Date on which final document/standards material was supplied to HQ

Jun 10, 2020

31. URL of publication material/ SVN repository

http://build.fhir.org/ig/HL7/cdisc-lab/index.html

32. Publishing Facilitator

Christine Denney / Hugh Glover

33. Special Publication Instructions

N/A

34. URL of ballot reconciliation document

https://confluence.hl7.org/display/BRR/CDISC+Lab+Semantics+in+FHIR

35. Has the Work Group posted its consideration of all comments received in its reconciliation document on the ballot desktop?

Yes

36. Substantive Changes Since Last Ballot?

No

37. Product Brief Reviewed By

BR&R (and approved via vote)

38. Date Product Brief Reviewed

Jun 23, 2020

39. Has the Product Brief changed?

Product Brief

Product Brief

40. Family

FHIR

41. Section

Implementation Guides

42. Topic

Laboratory Regulated Studies

43. Please Describe the Topic

44. Product Type

Implementation Guide

45. Parent standard

FHIR R4

46. Parent Standard Status

Active

47. Update/replace standard

N/A

48. Common name/search keyword

CDISC SDTM and CDASH mapping to FHIR for laboratory data

49. Description

FHIR provides an effective standard for sites and sponsors to utilize in exchanging clinical research laboratory data. The end-to-end process includes site data storage, site data preparation/transformation, production of FHIR format files, transformation from FHIR to CDISC laboratory data standards, and consumption of data by sponsor systems. This implementation guide focuses on mapping laboratory data from FHIR to CDISC.

Targets

Targets

These are categories of potential users, implementers, or other interested parties such as those that are indicated on the Project Scope Statement under “Stakeholders/Vendors/Providers”. Select those that are applicable, or suggest others:

50. Stakeholders

Clinical and Public Health Laboratories, Regulatory Agency, Standards Development Organizations (SDOs), Other (specify in text box below)

51. Vendors

Pharmaceutical, Health Care IT, Other (please specify)

52. Providers

Clinical and Public Health Laboratories

53. Benefits

Supports the exchange of laboratory information between data providers and clinical research sponsors. Enables translation of FHIR elements into elements that are more familiar to research sponsors and are part of their existing infrastructure for analysis and regulatory reporting (i.e., CDISC SDTM and CDASH domain variables).

54. Implementations/Case Studies

SCDM using this standard to define guidance for setting up FHIR servers for clinical research laboratories who send data to research sponsors.

Eli Lilly and Co. using this for local laboratory clinical research data.

MSK-CC and Dana Farber for exchange of laboratory data for oncology studies.

55. Development Background

A cross-industry effort began in 2017, to improve clinical research sponsors' ability to consume data in the FHIR standard. The team participated in multiple connectathons and worked together to harmonize the standards.







16 Comments

  1. Hugh Glover Boris Brodsky I believe the BR&R has to review and approve this product brief section (lines 40-55).

    Lloyd McKenzie  The form is asking for PMG review / date (see 12 & 12a above).  Is that you? 

  2. FMG review is triggered by an email to FMGContact@lists.hl7.org.  Next call will be 2 weeks today.  I'm certainly happy to represent the proposal on the call.

    1. Hi Lloyd McKenzie the BR&R has voted and approved the text for 49-55, so it is all ready for the FMG review/approval this week.  Please let me know if you have any questions.  Thank you!

  3. Hi Christine Denney Hugh Glover Boris Brodsky

    FMG reviewed and approved today. I can move this on to TSC approval, but it is missing a link to the reconciliation spreadsheet that must be uploaded to the ballot desktop. The line where the link should appear currently says "sent to Lloyd McKenzie." The spreadsheet must be present for TSC approval. If we can get that accomplished, I can send to TSC vote next week. Let me know if I can help - thanks! 

    1. Hi Anne Wizauer apologies for the confusion.  I had sent the ballot to Lloyd for loading by Josh and wasn't sure where the file was loaded.  I have attached the reconciled ballot to this page, down in the comments.

  4. Ballot reconciliation file attached.


  5. Hi Anne Wizauer , did this receive approval from TSC? Thanks for your help! -Christi

    1. Hi Christine Denney
      They did not approve it today. Melva just send a note to Hugh and Myron stating the following:

      "The TSC reviewed the publication request for the CDISC Lab Semantics in FHIR specification.  Concerns were raised about the use of CDISC in the name of the standard.  HL7 doesn’t currently have an agreement with CDISC so it isn’t appropriate to use CDISC in the name.  As a result, the TSC could not approve the publication request with the current title.  Please reconsider the title of this specification and re-submit it to the TSC for approval when a new name has been identified."

  6. Hi Anne Wizauer

    When this was being developed,  Wayne Kubick  was involved to make sure there were no legal issues, since TransCelerate Biopharma was the primary author.  In addition, Lloyd McKenzie  was involved in the naming of the IG.  This was originally called the Laboratory Data Implementation Guide, but the name was changed per O+O and BR&R guidance.  What would you suggest for a new title?  I am not opposed to a rename, I just want to make sure that all those involved in the naming are aware of this request.  Also, CDISC was a reviewer of this content and is aware of this IG.  (and supportive of it, in case there is a concern)

    Your thoughts, Christi

    cc: Hugh Glover Myron Finseth

  7. While my recollection is that the CDISC IP policy is focused on contribution to CDISC standards rather than derivative works, HL7 doesn't have permission to use "CDISC" in the name of an HL7 specification.  I'm not sure why Lloyd felt that adding CDISC to the title was appropriate, but I might suggest you use something like "Clinical Research Laboratory Data Implementation Guide" - more like the original title but clarifying that the scope is for research.  

  8. Having CDISC in the name makes sense when that's what we're mapping to.  Including the CDISC name when it's an adjective is not a violation of copyright.  If someone is searching for CDISC lab mappings, we want them to find this.  This isn't just a Clinical Research Laboratory Data  IG, it's a mapping of CDISC standards to FHIR.  Naming it otherwise is unnecessarily confusing.

  9. Anne Wizauer Wayne Kubick Lloyd McKenzie

    At today’s BR&R meeting, we voted to change the name to ‘Clinical Research Sponsor Laboratory Semantics in FHIR.’

    We will update the title and rebuild the IG. We will include CDISC in the search keywords, so this will appear in search results.

    Thanks!

    Cc: Hugh Glover Boris Brodsky 


    1. Christine Denney Sounds good! Let me know when the updates are complete to the IG and the publication request and I will send back to TSC e-vote.

  10. Hi Anne Wizauer

    We have made the updates to the title, rebuilt the IG (no errors or warnings), pushed to GitHub, and are ready for review by TSC.

    Thank you for your help!

    Christi

    cc: Hugh Glover Boris Brodsky

    1. Thank you! I will get this back to TSC vote.