Faculty Handbook

Institutional Review Board External Adverse Event Form

An adverse event is an undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention.

Unanticipated Problems that Affect Risks to Subjects (from “Guidelines for Researchers,” 11)

If adverse consequences or unanticipated side effects are encountered in the course of a study, or new information becomes available that could change the perception of a favorable risk/benefit ratio, the principal investigator is responsible for informing the Committee PROMPTLY.

A copy of every adverse event report, letter, or form submitted to an outside agency (e.g., a federal agency) should also be forwarded to the WestConn IRB in care of the Office of Grant Programs, 321 Warner Hall, within seven working days after discovery. The WestConn IRB will make the final determination regarding protocol changes required due to adverse event reports.

A. General Information
         
  Protocol Number: ____________________
     
  Principal Investigator: __________________________________________________________________________
         
  Protocol Title: ________________________________________________________________________________
         
B. Event Information      
         
  Adverse event date: _________________
         
  Adverse event (describe in 1 sentence): ___________________________________________________________
         
  ___________________________________________________________________________________________
         
C. Nature of the Event
         
  Submit this form ONLY if all three boxes are checked.
         
    _____ Unexpected_____ Related or possibly related_____ Serious
         
D. Principal Investigator's Signature: _______________________________________________ Date: _____________
         
  Do you expect this event to occur again: _____Yes_____No
         
  Is the event adequately described in the protocol and consent form? _____Yes_____No
         
  Should the protocol be modified to minimize this risk? _____Yes_____No
         
  Will the consent form be modified as a result of this adverse event? If so, please submit an amendment to the consent form. _____Yes_____No
         
  Will subjects be re-consented as a result of this adverse event? _____Yes_____No
         
  Describe the event, including the investigator’s analysis of the event. Use additional pages, if necessary.
         
  ____________________________________________________________________________________________
         
  ____________________________________________________________________________________________
         
  ____________________________________________________________________________________________
         
  ____________________________________________________________________________________________
         
  _____________________________________________________ ________________________________
  Principal Investigator's Signature   Date  
         
======================================= For IRB Use Only =====================================
         
  _____________________________________________________ ________________________________
  IRB Chair’s (or designee’s) Signature   Date  
         
  Further action by IRB: _____Yes _____No  

Last updated 7/12/07

 


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