New Event Reporting Form

University of Cincinnati IRB is Adopting Food and Drug Administration FDA “Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs- Improving Human Subject Protection January 2009.  http://www.fda.gov/cder/guidance/index.htm

“The guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the IRB under 21 CFR part 56, part 312 (Investigational New Drug Application), and part 812 (Investigational Device Exemptions).  The guidance provides recommendation to both sponsors and investigators conducting investigational new drug (IND) trials to help them differentiate between those adverse events that are unanticipated problems that must be reported to an IRB and those that are not.  The guidance also makes suggestions about how to make communicating adverse events information to IRB more efficient.”

Please note:  Starting immediately the University of Cincinnati Institutional Review Board (IRB) Office is replacing the following forms:  Adverse Event Form and Unanticipated Events Form with the following form,

"EVENT REPORTING FORM FOR UNANTICIPATED PROBLEMS INVOLVING RISKS TO PARTICIPANTS OR OTHERS, ADVERSE EVENTS AND OTHER PROBLEMS"

*The current Protocol Deviation Form will be available for deviations that are not considered serious or significant.  

**Serious or Significant protocol deviations should be reported using the Events Reporting Form.  

The Event Reporting Form must accompany any other documents that fall under Reportable Events, these include, but are not limited to Data Safety Monitoring Board (DSMB) Reports, Investigator Brochures and Subject Complaints.

The Event Reporting Form can be found on the IRB website at:  http://researchcompliance.uc.edu/irb/

Please feel free to contact the IRB Office with any questions at:

Telephone: (513) 558-5259