Adverse Event Report Form

Instructions for submitting an adverse event/problem report form:

  1. Complete each section of this form.
  2. Please be sure to use the grey form fields to complete this document.
  3. Do not change the format of the document.
  4. Please provide as much detail as possible.
  5. Save a copy of this form to your personal computer.
  6. Email the form to .
  7. Please cc your faculty advisor/mentor when submitting this form.
  8. Please note that we can only accept our forms in Microsoft Word format.
  9. In addition, please submit one signed copy of the form. This item can be submitted by email as a scanned document to or by fax to 434-522-0506.

Principal Investigator Contact Information
PI Name: / Email:
Title: / Mailing Address:
Department: / Phone:
Approval #: / Date of Submission:
Title of Study:
Faculty/Sponsor Contact Information
Name: / Email:
Title: / Mailing Address:
Department: / Phone:
Type of Event/Problem
Adverse event that is (1) unexpected, and (2) related/likely related to the research as determined by the Liberty University Principal Investigator
Specific protocol-defined events that require prompt reporting to the sponsor
Breach of confidentiality
An accidental or unintentional deviation from the IRB-approved protocol involving risks
An emergency protocol deviation without prior IRB review to eliminate an apparent immediate hazard to a research participant
A complaint of a participant that indicates an unanticipated risk or any complaint that cannot be resolved by research staff
Information that indicates a change to the risks or potential benefits of the research:
  • Example A: An interim analysis or safety monitoring report indicating that frequency or magnitude of harms or benefits may be different than when initially presented to the IRB
  • Example B: A paper published from another study indicating that the risks or potential benefits of the research may be different than when initially presented to the IRB

Incarceration of a participant in a protocol not approved to enroll prisoners
Sponsor imposed suspension for risk
Continuing Participation
1. Is the study permanently closed to enrollment?
Yes No N/A
2. Is anyone still involved in the current study and receiving treatment?
Yes No N/A
Location of Event
1. At a Liberty University or other LU Affiliated Location:
Yes No N/A
Indicate Location:
2. A site listed on the IRB application:
Yes No N/A
3. Other
Yes No N/A
Explain:
Problem/Event
Date of problem/event:
Date of discovery of problem/event, if applicable:
Identify device, treatment, intervention, etc., if applicable:
Briefly describe the problem/event:
Event Details
1. Has the problem/event occurred previously in this study?
Yes No
If Yes, what is the number of times this event has occurred?:
2. Is the problem/event ongoing?
Yes No
If No, what date did the problem end?:
3. Outcome of the event (check all that apply):
Participant was not adversely affected by the problem/event
Resulted in prolonged hospitalization
Resulted in permanent disability
Resolved spontaneously
Resolved with treatment
Participant discontinued study intervention
Participant withdrew from study
Other:
Participant died. Explain circumstances in detail:
4. Are the specificity, frequency, and severity of this problem/event consistent with the study and consent document?
Yes No
If No, explain why not:
5. Should the consent document be revised?
Yes No
6. Should the protocol be revised*?
Yes No
*If Yes, submit a Change in Protocol form with this report.
7. Should the research be suspended or terminated?
Yes No
8. Should currently enrolled participants be notified of this problem/event?
Yes No
*If yes, explain how they will be notified:
*If an addendum to the consent document will be used, submit this document and a Change in Protocol form with this report.
8. Should past participants be notified of this problem/event?
Yes No
*If yes, explain how they will be notified:
*If an addendum to the consent document will be used, submit this document and a Change in Protocol form with this report.

PLEASE CERTIFY YOUR RESPONSES PRIOR TO SUBMITTING:

By checking this box, I, [TYPE YOUR NAME] certify that all necessary information has been assessed and the risk-to-benefit ratio continues to be acceptable.

Date:

Comments:

1