If presented with a "Please wait..." screen on a PDF file on this page, save the electronic file to your computer and open it. For forms, complete the form on your device by adding any necessary information. Once the form is complete, re-save the document to your computer and submit it according to the instructions on the form.

Adverse event collection and reporting of unanticipated problems

Adverse event or unanticipated problems collection and reporting are required for all research studies whether a study is a clinical or non-clinical trial, or sponsor- or investigator-initiated.

Adverse event collection should document unfavourable changes in the current health status of the research participant or any incident, experience or outcome that suggests that the research may place participants or others at a greater risk of harm (including physical, psychological, economic or social harm).

The investigator must ensure the protocol outlines how adverse events will be defined, documented and monitored at the site and subsequently reported to the sponsor(s), Health Canada, and applicable regulatory authorities — such as the FDA, US Department of Health and Human Services — and the Research Ethics Board (REB). The investigator should review the Health Canada website for guidance on reporting requirements to regulatory agencies. 

Follow the reporting guidelines specific to the requirements for reporting adverse events and unanticipated problems to the University of Bannatyne Campus REBs.

Do not be concerned if you are over-reporting local adverse events to the REB at this time.

Background on UM procedures

The UM Bannatyne campus Research Ethics Board (REB) procedures for reporting of adverse events and safety information to the REB are based on the Canadian Association of Research Ethics Boards Guidance on Reporting of Unanticipated Problems, including Adverse Events to Research Ethics Boards in Canada.

Adverse events and unanticipated problems that must be reported to the REB

In each case, the forms provided here must be used to ensure the REB meets their review requirements.

Please review the instructions for each form before submitting to ensure you are following all procedures.

Local adverse event and unanticipated problems

External (non-local) adverse events 

Periodic safety updates

Updated safety information reporting requirements

In accordance with Articles 11.8 and 11.9 of the TCPS, researchers are required to promptly report new information that may affect the welfare and consent of participants to the REB, and the REB has a responsibility to develop procedures for reviewing such information.

Contact us

Please contact Shelly Rempel-Rossum for more information.

Office of the Vice-President (Research and International)
Shelly Rempel-Rossum
shelly.rempel-rossum@umanitoba.ca
204-789-3389