Guidance

Study-Specific AE Reporting

IRBMED
Mar 12, 2012 1:30 pm
Click to review previous steps      

Step 1

Step 2

Refer to the IRB-approved documents for the specific study that includes a detailed plan for AE reporting. Follow the directions in the plan for reporting to oversight bodies (e.g. DSMB, sponsor, IRB). Refer to the table below for additional details that may not be in the study documents.      

To report social, psychological or other non-physiological adverse events, not included in the study's AE reporting plan, follow the Standard AE Reporting Timetable.

  • Study Specific AE Reporting Timetable

                                         Study Specific AE Reporting Timetable
    Event or Report of Event Timing of IRB Submission Required Form
    UM adverse event or unanticipated problem reported to an oversight body     

    (Reports from the investigator to the FDA, DSMB/DSC, OBA, sponsor or others)

    Concurrently with report to other oversight body or as required immediately below eResearch: Enter the selected study and click Adverse Event / ORIO Button
    UM event of any severity designated in the AE Reporting Plan, DSMP, or IRB application as reportable to the UM-IRB     

    (i.e. Some IRB approved plans either allow the investigator additional time to report to the IRB after reporting to another oversight body OR require reporting to the IRB sooner than to other oversight bodies. You must refer to and follow the IRB approved plan)

    As required by the study AE Reporting Plan / DSMP eResearch: Enter the selected study and click Adverse Event / ORIO Button
    URGENT DSMB/DSC, Sponsor, OBA, or other report where one or more of the following applies:     
    • an unanticipated problem is identified
    • a change to the research is required
    • the risk/ benefit ratio of the study is negatively impacted
    • subjects' willingness to participate is or would be affected

    (These are reports received by the investigator from the outside source)

    Within 7 days of PI receipt eResearch:Enter the selected study and click Adverse Event / ORIO Button, then use "Report(s) to or from oversight entity"

    NON-URGENT DSMB/DSC, Sponsor, OBA, or other report where none of the criteria bulleted in the cell above applies.

    (These are reports received by the investigator from the outside source)

    In summary format prior to submission of Scheduled Continuation Application (IRB renewal) eResearch:Enter the selected study and click Adverse Event / ORIO Button, then use "Report(s) to or from oversight entity"
    Additional Considerations: Follow these links for clarification of social, psychological, or non-physiological events.     

    Any other UM adverse events that the DSMP may not explicitly require be reported to an oversight body should be reported to IRBMED if they occur with unexpected magnitude, duration, or frequency. Report with the study renewal (the Scheduled Continuation Application) unless otherwise warranted.

    Updated 3/12/12

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: bpsea@umich.edu
Last Updated: June 1, 2018 10:00 AM