Reporting Date:
____________________________
Institutional Review Board
Grants and Research Office
Adverse Event and Unanticipated Problems Involving Risks to Others Initial Report
Study Information
Name of Primary Investigator:
Reporting Investigator:
Phone (xxx) xxx-xxxx:
Email:
Project Title:
IRB Tracking #:
Initial Approval Date:
Expiration Date:
Have there been previous adverse events associated with this study?
Yes
No
Study Status
Study is recruiting participants
Study is closed to recruitment, but intervention or interaction with participants continue
Data analysis only
Study has ended or expired
Details of Adverse Event
Date(s) Event Occurred:
Place(s) Event Occurred:
Number of Participants Involved:
Has the participant(s) been involved in prior adverse events related to this study?
Did the participant(s) withdraw from the study?
Yes
Yes
No If yes, when?
Description of Adverse Event or Unanticipated Problem Involving Risks to Others
Was the event directly related to any part of participation in the study? Please explain in detail.
Revised 06/22/2016
No
Please check the nature of the event:
Unexpected Adverse Events are those events that ARE NOT included as a possible risk in the Informed Consent
Form.
Expected Adverse Events are those events that ARE included as a possible risk in the Informed Consent Form.
Serious Events: The FDA defines an event as serious that results in any of the following outcomes:
death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, a persistent or
significant disability/incapacity, a congenital anomaly/birth defect, or an event that jeopardizes the Human Subject and
may require medical or surgical treatment to prevent one of the preceding outcomes.
Please provide a description of the event or problem. Be as specific as possible by providing detail.
What measures, if any, have been taken by the investigators since the event occurred to address any issues which
caused an adverse event?
Revised 06/22/2016
Important Notes:
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Please attach a copy of the involved signed Consent Form(s) to this report.
If the Primary Investigator is not the investigator reporting the event, the reporting investigator
must also sign this form.
The IRB will review your initial report and respond with an action based on the report.
Primary Investigator Signature: ______________________________________________________
Date: ___________________
Reporting Investigator Signature: ____________________________________________________
Date: ___________________
Received: _________________________________________________________________________________
Date: ___________________
Revised 06/22/2016