Age units should be pre-specified according to the study protocol

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    • Type: Change Request
    • Resolution: Persuasive with Modification
    • Priority: Very High
    • CDISC Mappings (FHIR)
    • 0.1.0
    • Biomedical Research & Regulation
    • Demographics
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      The units issue applies to more than just 'age'. We will add a new sentence following "...either through additional filters, additional transformation, or occasionally looking for information in alternate locations".

      "Specifically, relevant clinical trial documentation will have expectations around units, other code systems and data consistency that may not be met by RWD and conversion and mapping may be necessary."

       

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      The units issue applies to more than just 'age'. We will add a new sentence following "...either through additional filters, additional transformation, or occasionally looking for information in alternate locations". "Specifically, relevant clinical trial documentation will have expectations around units, other code systems and data consistency that may not be met by RWD and conversion and mapping may be necessary."  
    • Rebecca Baker/Christi Denney : 19-0-6
    • Clarification
    • Non-substantive

      For Age Units, should it be pre-specified, age value can be calculated, but units should be pre-specified according to the study protocol

      (Comment 27 - imported by: Lloyd McKenzie)

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

              Created:
              Updated:
              Resolved: