AE Reporting

Reporting Information

Follow the "AE Reporting Steps" below and on the linked pages to determine when specific events should be reported to the IRBMED.

Please note that this guidance is for reporting to IRBMED only and does not satisfy required reporting by an investigator to other internal or external oversight agencies or departments (e.g. the FDA, UMHS Compliance or Privacy Offices).

Step 1

Is this an UM Event?

YES
Follow Standard AE Reporting 		NO
Follow External Unanticipated Problem/AE Reporting
  • Initial and/or follow-up reports of adverse events that are judged by the study sponsor or principal investigator to constitute an 'unanticipated problem'
  • Events are considered 'external' to this UM study when subject(s) or patient(s) are at other institutions where a non-UM IRB has direct oversight of the investigators and subjects.
  • Note: If submitting an adverse event that is not an 'unanticipated problem' the investigator must provide a justification for why the report is being submitted.