1. Reporting Adverse Events and Unanticipated Problems to the UAB IRB Policy and Procedure Change September 22, 2006 Amanda G. Murphy, RN, CIP Assistant Director, IRB

2. From the Policy… UAB Policy requires that unanticipated problems involving risks to research subjects or others must be promptly reported to the IRB, the Institutional Official, the sponsor, and appropriate federal agencies.

3. Who Does What? The Investigator reports the problem/event to the Office of the IRB The IRB determines whether the problem/event alters the risk of the research, and must promptly report its determination and actions to the PI and the Institutional Official (IO) The IO is responsible for promptly reporting the IRB findings to the sponsor and applicable federal agencies

4. From the Procedure… Investigators, or their designees, must report “REPORTABLE EVENTS” to the OIRB for UAB IRB consideration

5. All Reportable Events Must be reported promptly to the Office of the IRB The IRB has defined promptly as within 10 days of the study staff’s knowledge of the event

6. Four Types of REPORTABLE EVENTS 1.Adverse events that are serious, unexpected, AND related or possibly related to participation in the research 2.Serious adverse events that are expected in some subjects, but are determined to be occurring at a significantly higher frequency or severity than expected 3.Other adverse events that may alter the IRB’s analysis of the R/B ratio and, as a result, warrant consideration of substantive changes to the protocol or consent document 4.Unanticipated problems not involving adverse events that occur and result in new circumstances which increase the risk of harm to subjects or others

7. The Investigator/Study Staff Must submit reportable events to the OIRB on the revised Adverse Event Report Retain all reportable events for submission in a summary format at continuing review Report other adverse events in a summary format at continuing review

8. GREAT NEWS!!! The change in IRB’s Policy and Procedure will result in fewer Adverse Event Reports less time to prepare the Investigator’s Progress Report

9. So What do You do?? Complete the revised Adverse Event Report whenever you have knowledge of a reportable event

10. You don’t have to… Submit as many Adverse Event Reports!

11. The New Form…What does the IRB want, where?

12. Report Information

13. Protocol Information

14. Event Information

15. Reporting and Actions

16. Other Changes The OIRB will return to the investigator reports of events that do not meet the criteria for “reportable events” Each reportable event must be reported on a separate Adverse Event Report

17. More Good News! The Summary Format At the time of continuing review For non-reportable events, you’ll use the Summary Log Sheet For reportable events, you can copy/paste the information from the report forms to the log sheet, instead of photocopying Adverse Event Reports

18. Special Notes The revised form and summary tables do not have final IRB approval, so there may be some MINOR changes

19. Questions?