Uploaded image for project: 'FHIR Specification Feedback'
  1. FHIR Specification Feedback
  2. FHIR-42038

AE Reporting Process

    XMLWordPrintableJSON

Details

    • Icon: Change Request Change Request
    • Resolution: Persuasive
    • Icon: Highest Highest
    • Adverse Event Clinical Research (FHIR)
    • current
    • Biomedical Research & Regulation
    • Withdrawn
    • AdverseEvents for Clinical Research Home Page
    • Hide

      The narrative will be edited as requested. Comments contain a working draft of the edit to be made. 

      Show
      The narrative will be edited as requested. Comments contain a working draft of the edit to be made. 
    • Peter Bomberg / Rebecca Baker : 16 - 0 - 2
    • Clarification
    • Non-substantive

    Description

      The statement "In the pre-market clinical research setting, serious adverse events must be reported to the sponsor, clinical research organization, and regulatory agencies within a specific time frame for Institutional Review Boards (IRBs) and Data Safety Monitoring Board (DSMB) review" does not seem to be totally sound, the reason being that the submission of AEs to FDA is not exactly for IRB or DSMB review. In addition, submission of all AEs including non-serious AEs are expected in support of product marketing application.

      Attachments

        Activity

          People

            bheale Bret Heale
            mrocca Mitra Rocca
            Watchers:
            4 Start watching this issue

            Dates

              Created:
              Updated:
              Resolved: