AETERM and AEDECOD are mapped to Condition.code

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    • Type: Change Request
    • Resolution: Not Persuasive
    • Priority: Highest
    • CDISC Mappings (FHIR)
    • 0.1.0
    • Biomedical Research & Regulation
    • Adverse Events
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      Condition.code is a CodeableConcept, which means it can have multiple codings. Multiple codes (both unmodified and modified, as well as at varying levels of granularity) can all be present so long as they're all describing the same Condition at some level of granularity. Clinical systems can choose to capture Meddra terms for their AdverseEvent conditions, though if not captured specifically for research purposes, the most likely case is that the Condition will be captured in something like SNOMED and will then need to be mapped to Meddra.

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      Condition.code is a CodeableConcept, which means it can have multiple codings. Multiple codes (both unmodified and modified, as well as at varying levels of granularity) can all be present so long as they're all describing the same Condition at some level of granularity. Clinical systems can choose to capture Meddra terms for their AdverseEvent conditions, though if not captured specifically for research purposes, the most likely case is that the Condition will be captured in something like SNOMED and will then need to be mapped to Meddra.
    • Clarification

      The controlled terminology for Condition.code is not clear, why AETERM and AEDECOD are mapped to condition.code. Additional AELLT, AEHLT and AESOC and etc. should be included. This is the heart of AE. When will Condition.code become a meddra term?

      Existing Wording:

      AETERM and AEDECOD are mapped to Condition.code

      (Comment 9 - imported by: Lloyd McKenzie)

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

              Created:
              Updated:
              Resolved: