Why are there novel concepts?

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    • Type: Technical Correction
    • Resolution: Not Persuasive
    • Priority: Highest
    • CDISC Mappings (FHIR)
    • 0.1.0
    • Biomedical Research & Regulation
    • Medical History
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      These concepts are from the SDTM v1.4 which were published in 2013.  The SDTMIG v3.2 which the mapping is based on corresponds with the SDTM v1.4; it provides details about the definitions and examples.

      The FHIR to CDASH mapping document goes from FHIR to CDASH v2.1 which is based on SDTMIG v3.2 based on SDTM v1.4.

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      These concepts are from the SDTM v1.4 which were published in 2013.  The SDTMIG v3.2 which the mapping is based on corresponds with the SDTM v1.4; it provides details about the definitions and examples. The FHIR to CDASH mapping document goes from FHIR to CDASH v2.1 which is based on SDTMIG v3.2 based on SDTM v1.4.

      The remaining items in the mapping appear to depart from CDISC Controlled Terminology and employ novel concepts (e.g. MHPTCD, MHHLT and others). Without a clear definition of the terminology and use case, there will be a large variation of application hindering a consistent review.

      Existing Wording:

      Medical History Event Lowest Level Term, MH Event Lowest Level Term Code, etc.

      (Comment 34 - imported by: Lloyd McKenzie)

            Assignee:
            Unassigned
            Reporter:
            mrocca
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              Created:
              Updated:
              Resolved: