University of Southern California
University Park Institutional Review Board
Reporting Adverse Events Occurring at USC
All incidents of injury or other adverse effects experienced by subjects in research must be reported to the UPIRB. This report should be submitted as soon as possible, but no later than 5 working days after first awareness of the problem. The investigator should provide his/her opinion and support for any proposed changes in the protocol and/or consent form. (Only typed forms will be accepted.)
Date of Report: ______
A. Approved Protocol Data
UPIRB # ______
Title of Project: ______
______
Principal Investigator: ______
Co-PI/Student Investigator:______
Telephone Number(s): ______
School/Department: ______
Campus Address (including Mail Code): ______
Number of subjects to be enrolled: ______
Number of subjects enrolled to date: ______
Number of total adverse events occurring at USC to date: ______
B. Description of Adverse Event
Date of Adverse Event: ______
The adverse event was: _____ mild; _____ moderate; _____ severe; _____ fatal
Relationship to protocol: ____ not related; ____ possibly related; ____ related;
____unknown
Provide a brief description of injury/adverse events, including the subject’s demographic information, as well as what actions the investigator(s) have taken in following up with the adverse event. A separate sheet may be attached if more space is needed.
C. Changes Necessitated by Injury/Adverse Effects
Change in Protocol: In your judgment, is a change in your protocol necessary to reduce or eliminate risk?
____ Yes (if checked, attach two copies of a revised protocol with changes highlighted on one copy.)
____ No (if checked, provide a brief rationale below.)
Change in Informed Consent/Assent Document(s): Are any changes required in the informed consent/assent document(s) to better inform and protect the rights and welfare of subjects?
____ Yes (if checked, attach two copies of a revised consent form with changes highlighted on one copy. Note that no new subjects may be entered until the revised consent form is approved by the UPIRB.)
____ No (if checked, provide a brief rationale below.)
Re-Consent/Assent: Is it necessary to inform subjects/legal representatives who have already consented to participation in the study of the adverse event?
____ Yes (if checked, attach two copies of a revised protocol or a revised consent form with changes highlighted on one copy.)
____ No (if checked, provide a brief rationale below.)
D. Additional Comments: A letter explaining additional details may be attached.
Please submit completed and signed form to:
USC University Park IRB, GFS 226, Los Angeles, CA 90089-1695
______
Signature of Principal Investigator (Faculty Sponsor) Date
______
Signature of Co-PI/Student Investigator Date
AE Form – UPIRB
Rev. 4/29/03 Page 2