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  1. FHIR Specification Feedback
  2. FHIR-38811

AdverseEvent - Section 9.9.1

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    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Highest Highest
    • FHIR Core (FHIR)
    • R5
    • Patient Care
    • AdverseEvent
    • Section 9.9.1
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      Add:  In clinical research trials, serious adverse events are usually required to be reported to the respective health authorities (e.g., U.S. FDA)

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      Add:  In clinical research trials, serious adverse events are usually required to be reported to the respective health authorities (e.g., U.S. FDA)
    • Dan Rutz / Rik Smithies : 9-0-1
    • Clarification
    • Non-substantive
    • R5

    Description

      For clinical research, I think it's important to mention that there's a regulatory requirement to communicate serious adverse events (e.g., https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.32#:~:text=Adverse%20event%20means%20any%20untoward,life%2Dthreatening%20suspected%20adverse%20reaction.) 

      Verbatim:
      "In the clinical research setting, the event is additionally tracked and evaluated as part of the clinical research process for the research study, since the occurrence of an adverse event may surface a potential confounder or a potential side-effect of the study treatment."

      Addition:
      "In clinical research trials, serious adverse events are required to be reported to the respective health authorities (e.g., U.S. FDA)"

       

       

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            mhamidi Mike Hamidi
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