Adverse Event Reporting and Safety Information

Rationale and Background for new Reporting Requirements
Adverse Event Collection/Reporting of Unanticipated Problems
Adverse Events/Unanticipated Problems that must be reported to the REB
Updated Safety Information Reporting Requirements


Rationale and Background for new Reporting Requirements

The University of Manitoba, Bannatyne Campus Research Ethics Board (REB) have developed amended procedures  relating to the  reporting of adverse events and safety information to the REB  based on the Canadian Association of Research Ethics Boards Guidance on Reporting of Unanticipated Problems including Adverse Events to Research Ethics Boards in Canada. The guidance document was developed in response to concerns raised by the REB community in Canada regarding the over-reporting of adverse events, in particular, the increasingly large volumes of individual external (non-local) adverse event reports  as well the need to  standardize reporting to REBs across the country. The Bannatyne forms have also been modified to ensure there is appropriate documentation of the REB's review of these events.

Please begin submitting the adverse events as per the new procedures and forms immediately. The following forms will replace our previous Non-local SAE , Local SAE and Investigators Brochure Forms.  You will note that there is a section on each form which provides documentation for REB review. These forms must be used to ensure the REB meets their review requirements.


Adverse Event Collection/Reporting of Unanticipated Problems

Adverse Event or Unanticipated Problems collection and reporting are  required for all research studies regardless of whether it is a clinical or non-clinical trial, sponsor or investigator initiated.  Adverse event collection should document  unfavourable changes in 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, applicable regulatory authorities (e.g.  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. 

The following guidelines will provide guidance and instructions specific to the requirements for reporting adverse events and unanticipated problems to the University of Bannatyne Campus REBs.


Adverse Events/Unanticipated Problems that must be reported to the REB

Local Adverse Events

SOP REB 10 - Local Adverse Event Reporting (including pregnancy reporting) 

Bannatyne Campus Research Ethics Board -Local Adverse Event/Unanticipated
Problems Form (Initial)

Bannatyne Campus Research Ethics Board -Local Adverse Event/Unanticipated
Problems Form (Follow-up)
 

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

External (Non-local) Adverse Events (EAEs)

SOP REB 10A - External Adverse Event Reporting

Bannatyne Campus Research Ethics Board External Adverse Event Report Form 

NOTE:  Very few individual (if any individual EAEs) will require reporting to the
REB with these guidelines.

Periodic Safety Report Submission

Bannatyne Campus Research Ethics Board Periodic Safety Report Submission Form


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.  Examples of updated study safety information to be reported  include, but are not limited to the following:

  • Data Safety Monitoring (DSDM) report 
  • Audit or monitoring report 
  • Interim study results 
  • Health Canada, FDA or other regulatory agency study results 
  • Safety Alerts 
  • Publication in the literature or other findings 
  • Revised Investigators Brochures 
  • Notification of Sponsor suspension or termination of the study
  • Changes in the Health Canada or FDA labeling or withdrawal from marketing of a drug, biologic or device used in a research protocol

SOP REB 10B - Updated Safety Information Reporting 

Bannatyne Campus Research Ethics Updated Safety Information and Reporting Form

Please contact Shelly Rempel-Rossum at 204-789-3389 with any questions you may have regarding the new reporting requirements.