AEYN is intended to be a prompt

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    • Type: Question
    • Resolution: Considered - Question answered
    • Priority: Highest
    • CDISC Mappings (FHIR)
    • 0.1.0
    • Biomedical Research & Regulation
    • Adverse Events
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      When converting from FHIR, there won't be a 'prompt' for an adverse event except as in a QuestionnaireResponse. Once data is expressed in FHIR, there'll either be an AdverseEvent or there won't. There's no support for an AdverseEvent instance that represents an AE that did not occur

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      When converting from FHIR, there won't be a 'prompt' for an adverse event except as in a QuestionnaireResponse. Once data is expressed in FHIR, there'll either be an AdverseEvent or there won't. There's no support for an AdverseEvent instance that represents an AE that did not occur

      The mapping instruction for AEYN says "In FHIR, this would be determined by searching for AdverseEvents with a given subject ...". But the purpose of AEYN in CDASH is to serve as a prompt question to ensure the AE is to be recorded in the system (or is deliberately left as no AE record). so it is not mean to serve as data query result.

      (Comment 17 - imported by: Lloyd McKenzie)

            Assignee:
            Unassigned
            Reporter:
            mrocca
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            2 Start watching this issue

              Created:
              Updated:
              Resolved: