Definitions, Criteria and Submission Instructions

Definitions:

External (non-local) Adverse Event (EAE): 

• Adverse events experienced by research participants enrolled by investigator(s) at other centres/institutions outside the REB’s jurisdiction.

Criteria for submission:

Only EAEs or other external unanticipated problems that meet ALL of the following criteria are to be reported to the REB:

• Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the REB-approved research protocol and informed consent document, or the Investigator Brochure; and (b) the characteristics of the research participant population being studied; and
• Related or possibly related to participation in the research, (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the investigational product(s) or procedures involved in the research); and
• A serious adverse event or incident, experience or outcome that suggests that the research places research participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized; and
• Requires a change to the protocol and/or consent form and/or require immediate notification to participants for safety reasons.

Only individual EAE reports or other unanticipated problems that include the ALL of following will be accepted by the REB:

• The description of the serious and unexpected event and why it is considered an unanticipated problem; and
• All the previous safety reports concerning similar adverse events; and
• An analysis of the significance of the current adverse event in light of the previous reports; and
• The proposed protocol changes, informed consent form changes or other corrective actions to be taken by the sponsor in response to the event.

Submitting Instructions:

• Upon becoming aware of an External Adverse Event (EAE) or other incidents it is the Investigator’s responsibility to review each report to ensure it meets the reporting criteria outlined above.
• Complete and submit two (2) copies of the Bannatyne Campus EAE form for each file along with one (1) copy of the sponsor generated report within fifteen (15) days of becoming aware of the unanticipated EAEs.  Include a self-addressed (postage attached for external mail) returned envelope.
• Incomplete submissions/documents or submissions that do not meet the criteria listed above will not be processed and will be returned to the sender. Sponsor documents must meet the reporting criteria listed above or the EAE report will not be accepted.
• Changes required to the protocol or consent form must be submitted using the Bannatyne Campus Amendment Form.
• Do not include a cover letter with the submission.
• Faxed or e-mail submissions are not accepted.