Adverse Event Report Form

		Definitions
		Adverse event
		Serious adverse event

All serious adverse events must be reported to the Secretary, O-REB within 2 days

All other adverse events must be reported to the Secretary, O-REB within 7 days.

REB Project Identification Number:

Title of Research Project:

Principal Investigator:

Please describe what happened in the adverse event, including, e.g.:

A full description of its impact on the subject

When and where it happened

How it was brought to the attention of the research team

The present state and prognosis of the research subject.

How many subjects have been recruited to the research project?

How many have completed their involvement in the research?

Have any other subjects shown any signs of comparable adverse events?   Yes   No

If yes, please describe

Have any other subjects suffered adverse events in the trial  Yes  No

If yes, please describe them

Were these adverse events reported to O-REB?  Yes  No

If yes, when?
If no, please explain

In your view, is this adverse event related to the intervention being studied in the research?  Yes  No

Please explain the reasons for your reply

In your view, does this adverse event require changes to any of the information or the consent form on which the O-REB based its decision to give ethics approval to this project?  Yes  No

Please explain the reasons for your reply

Has this project been considered, or is it being considered, by any other REB (or equivalent)?  Yes  No

If yes, please identify the other REB(s)
Please provide all information being sent to the other REB(s) about this adverse event.

Signature: __________________________________

Name (print): _____________________________

Date: _____________________________

Responsibility in research team.