Adverse event report form

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.

Adverse event report form

REB project identification number:

Title of research project:

Principal Investigator:

  1. Please describe what happened in the adverse event. Include examples.
  2. A full description of its impact on the subject.
  3. When and where it happened.
  4. How it was brought to the attention of the research team.
  5. The present state and prognosis of the research subject.
  6. How many subjects have been recruited to the research project?
  7. How many have completed their involvement in the research?
  8. Have any other subjects shown any signs of comparable adverse events? Yes No
  9. If yes, please describe.
  10. Have any other subjects suffered adverse events in the trial? Yes No
  11. If yes, please describe them.
  12. Were these adverse events reported to O-REB? Yes No
  13. If yes, when? If no, please explain.
  14. In your view, is this adverse event related to the intervention being studied in the research? Yes No
  15. Please explain the reasons for your reply.
  16. 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
  17. Please explain the reasons for your reply.
  18. Has this project been considered, or is it being considered, by any other REB (or equivalent)? Yes No
  19. If yes, please identify the other REB(s).
  20. Please provide all information being sent to the other REB(s) about this adverse event.

Responsibility in research team.

Signature:

Name (print):

Date: