Many of the CDISC AE variables are not included in the mapping

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    • Type: Change Request
    • Resolution: Persuasive with Modification
    • Priority: Highest
    • CDISC Mappings (FHIR)
    • 0.1.0
    • Biomedical Research & Regulation
    • Adverse Events
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      General scope was not to include variables that would not come from source data. 

      All the missing variables are not collected with the exception of the USUBJID which is mapped in other places.

      The BODSYS variable, which is dictionary-derived and would be coded values.

       

      Will add USUBJID.

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      General scope was not to include variables that would not come from source data.  All the missing variables are not collected with the exception of the USUBJID which is mapped in other places. The BODSYS variable, which is dictionary-derived and would be coded values.   Will add USUBJID.
    • Rebecca Baker/Christi Denney : 19-0-6
    • Clarification
    • Non-substantive

      Many of the CDISC AE variables are not included in the mapping (ex: DOMAIN, USUBJID, AESEQ, AEGRPID, AEBODSYS, ..). Perhaps the included CDISC variables were selected based on CDASH only? But certain AE variables in CDASH are missing as well (ex: USUBJID). Anyway, how the mapping items are selected should be explicitly explained.

      (Comment 14 - imported by: Lloyd McKenzie)

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

              Created:
              Updated:
              Resolved: