Faculty Handbook

Institutional Review Board Internal 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’s Name: ____________________________________
         
  Protocol Title: ________________________________________________
         
B. Event Information      
         
  Adverse event date: _____________      
         
  Subject’s ID number: ____________      
         
  Adverse event (describe in 1 brief sentence): _______________________________________________________
         
  __________________________________________________________________________________________
         
  The adverse event appears to be: ______ Serious _____ Moderate _____ Unexpected
         
  Based on your review of the information, what is the relationship of the event to the research?
       
  ______ Definite; clearly related to the research    
       
  ______ Probably; likely related to the research    
       
  ______ Possible; may be related to the research    
       
  ______ Unlikely; doubtfully related to the research    
       
  ______ Unrelated; clearly unrelated to the research    
         
  In your opinion, 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 yes, please submit an amendment to update the consent form.
_____ Yes _____ No
  Will the subjects be re-consented as a result of this adverse event? _____ Yes _____ No
         
  Please describe the adverse 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 the IRB: _____ Yes _____ No  

Last updated: 6/27/06

 


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