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  1. FHIR Specification Feedback
  2. FHIR-42035

AE Definition

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    • Icon: Change Request Change Request
    • Resolution: Persuasive
    • Icon: Highest Highest
    • Adverse Event Clinical Research (FHIR)
    • current
    • Biomedical Research & Regulation
    • STU
    • AdverseEvents for Clinical Research Home Page
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    • Peter Bomberg / Rebecca Baker : 16 - 0 - 2
    • Clarification
    • Non-substantive

    Description

      Suggest using the FDA and ICH definition of an adverse event:
      Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.

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            bheale Bret Heale
            mrocca Mitra Rocca
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              Updated:
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