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.
|Protocol number: ________________________|
|Principal Investigator’s Name: ____________________________________|
|Protocol Title: ________________________________________________|
|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
|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