SHAW UNIVERSITY INSTITUTIONAL REVIEW BOARD (IRB)
For IRB use only
Date received:
ADVERSE EVENT REPORTING FORM
IRB #:
INSTRUCTIONS
Adverse Events (AE) and Serious Adverse Events (SAE) must be reported to the IRB by the Principal Investigator (PI)
as soon as possible after an event is discovered. The adverse event reporting form must be submitted to the IRB
office (Room 105, Estey Hall). In the event of a SAE the PI must also call the IRB at 919-719-1891 immediately.
Principal Investigators should advise all research personnel of the proper procedures for reporting such events. The
IRB uses the following definitions:
Adverse Event (AE) – an event occurring during the course of a research project that is undesirable and unintended,
that results in injury, either physical or psychological/emotional.
Serious Adverse Event (SAE) – an adverse event that results in death or is life threatening, results in serious injury or
disability, requires hospitalization or prolongation of an existing hospitalization, or results in a congenital anomaly/birth
defect.
INVESTIGATOR INFORMATION
IRB #:
Protocol Title:
Principal Investigator:
Title:
Department:
Campus Address:
Phone #:
Fax #:
AE/SAE INFORMATION
Description of Event:
Adverse Event (AE)
Email:
Serious Adverse Event (SAE)
Date AE/SAE was discovered:
Date of the event:
Did the event result in: (check all that apply):
Death
Hospitalization
Injury
Prolongation of hospitalization
Disability
Congenital anomaly/birth defect
Describe the event (number of participants affected, where/when the event occurred, relevant information
about those affected, etc.):
Principal Investigator’s Signature _________________________________
Date ____________
Faculty Advisor’s Signature ______________________________________
Date _____________
For IRB Use Only
IRB Chair Signature: _______________________________________________
Date: ______________________
Result of review ______________________________________________________________________________________
Version 10-27-05
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