Research Ethics Board

Adverse/Unanticipated Event Reporting Form

An Adverse Event is any unfavourable change in current health status (including mental, emotional or psychological) in a person participating in a research study. This change may or may not be causally related to the study protocol.
An Unanticipated Event is any unfavourable or unintended occurrence during the course of a research study which may have real or potential implications for participants.
This form should be used to report:
  • Any unanticipated event relevant to a research ethics protocol (e.g. health-related event, breach of confidentiality, protocol violation, participant complaint).
  • Any Adverse Event or Adverse Drug Reaction occurring to a participant in a Women’s CollegeHospital REB-approved protocol.Please include a copy of the Sponsor’s report where available.
Submit 2 typed, copies of this form with original signature to the REB office for review.

Date Submitted (dd/mmm/yyyy):

SECTION 1: Study Identification

WCH REB Number: Sponsor: Expiry Date:

Study Title:

Number of participants recruited to date at WCH:

List of safety reports #s as referenced in Sponsor’s report:

Is this a follow-up report to an earlier report? Yes No

If YES, indicate date of initial report:

SECTION 2: Contact Information

Principal Investigator:

Department/Division/Program:

Telephone: Fax Number:

Email Address:

Name of Person Completing the Form:

Telephone: Fax Number:

Email Address:

SECTION 3: Location

Did the event(s) occur at WCH? Yes No

If YES, please provide details below

SECTION 4: Monitoring

Is there a Data Safety Monitoring Board (DSMB) Yes No

If YES, has the DSMB been informed of this adverse event that occurred at WCH? Please provide details below

SECTION 5: Description of Adverse/Unanticipated Event

Date of Event (dd/mmm/yyyy):

What action (if any) has been taken, or will be taken at WCH and by whom?

What action (if any) has been taken, or will be taken, by the research team?

SECTION 6:Principal Investigator’s Further Comments

SECTION 7: Statement of Principal Investigator

I am aware of and understand the circumstances and/or information related to the adverse/unanticipated event referred to on this form. I have assessed the significance of this event with respect to participants in this research and as a result, I believe that:

The study should continue without change to the protocol: Yes No

The study should continue without change to the consent form: Yes No

If you answered NO to either question, please enclose one clean copy of the revised protocol and/or consent form and one marked copy with highlighted changes.

This signature attests that the PI has reviewed the SAE and its safety implications, has assessed the relationship to the study intervention of the SAE and attests to the accuracy of the form.

Printed name of PI / Signature / Date (dd-mmm-yyyy)

To Be Completed By the REB:

I acknowledge that the Women’s CollegeHospital Research Ethics Board has reviewed the documents listed above.

Name of REB Member / Signature / Date (dd-mmm-yyyy)

WCH REB – Adverse & Unanticipated Event Report FormVersion Date: 21-Apr-2011

Women’s College Hospital REB – 790 Bay Street, Room 750, TorontoONM5G 1N8

Telephone: 416-351-2535 Fax: 416-351-3746Page 1 of 2