Clarify PRLLT and PRDECOD comments

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    • Type: Change Request
    • Resolution: Persuasive with Modification
    • Priority: Highest
    • CDISC Mappings (FHIR)
    • 0.1.0
    • Biomedical Research & Regulation
    • Procedures
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      Will reword the sentence in PRLLT to "Translation of Procedure.code to MeDRA will typically be performed by the sponsor and not provided in FHIR source data."

      Will similarly reword the statement on PRDECOD to "Translation of the source-system-determined procedure code to the study-defined value set may need to be performed by the sponsor"

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      Will reword the sentence in PRLLT to "Translation of Procedure.code to MeDRA will typically be performed by the sponsor and not provided in FHIR source data." Will similarly reword the statement on PRDECOD to "Translation of the source-system-determined procedure code to the study-defined value set may need to be performed by the sponsor"
    • Rebecca Baker/Mike Hamidi: 15-0-3
    • Clarification
    • Non-substantive

      The mapping comment "Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR\." is not clear\. It may lead the reader to interprete it as the FHIR element Procedure\.Code is completed by the sponsor (which would be incorrect)\. suggested revision: "The medical coding of procedures is performed by the sponsor - not expected to\.\.\."

      Also, the current mapping comments for PTLLT and PRDECOD are very different\. The comment for PRDECOD "Define and review standardized coding schema with coding translations are conducted by the sponsor" is not easily understandable either\. It is important that the mapping instructions and comments for PRLLT and PRDECOD be written in a consistent and easy-to-understand manner\.

      Existing Wording:

      Procedure Lowest Level Term - PRLLT

      (Comment 47 - imported by: Lloyd McKenzie)

            Assignee:
            Unassigned
            Reporter:
            mrocca
            Watchers:
            2 Start watching this issue

              Created:
              Updated:
              Resolved: