Adverse event reporting

Adverse event (AE): Any occurrence in the health or well-being of a research participant who is administered an investigational product (drug, natural health product or device) or any other procedure(s) involved in the research or participates in a research activity that may or may not be caused by the administration of an investigational product or any procedure(s) involved in research

Unanticipated problem: any incident, experience, or outcome that meets all of the following criteria:

• 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
• 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.

A serious adverse event (SAE) is an adverse event that:

• Results in death; or
• Is life-threatening; or
• Requires in-patient hospitalization or prolongation of existing hospitalization; or
• Results in persistent or significant disability or incapacity; or
• Causes congenital malformation/ birth defect; or
• Any other adverse event that, based upon appropriate medical judgment, is an important medical event that may jeopardize the health (physical, psychological, economic or social) of the research participant or may require medical intervention to prevent one of the outcomes listed above.

Local (internal) adverse event: Local adverse events are those adverse events experienced by research participants enrolled by the investigator(s) at one or more centres under the jurisdiction of the University of Manitoba REB. In context of a single-centre clinical trial, all adverse events would be considered local adverse events.

• Report only those local adverse events that are considered unanticipated problems (i.e. unexpected, related or possibly related and places participants at greater risk).
• The reporting requirements apply to non-intervention trials as well as intervention (clinical) trials.
• Complete and submit one electric copy of the Bannatyne Campus Local Adverse/Unanticipated Problems Form (Initial) via email to bannreb@umanitoba.ca.
• Subject line of the email must be formatted as follows:
  • HS (REB#) – Local Adverse Event Form
• Acknowledgment of receipt will not be issued. Retain e-mail to verify submission to the REB.
• Submit all fatal or life-threatening adverse events that are unexpected and related or possibly related (i.e., unanticipated problems) to the REB within seven days of becoming aware of the event.
• Submit all other unanticipated problems (local) and reportable adverse events to the REB within 15 days of becoming aware of the event.
• Serious adverse events must also be reported to the study sponsor, as the sponsor is responsible for submitting safety information to applicable regulatory authorities.
• When the study is funded by the US Department of Health and Human Services (e.g., NIH, CDC, or other) the sponsor or lead Principal Investigator is also responsible to report the unanticipated local adverse event and other local unanticipated problems to the applicable agency head (or designee) and the Office of Human Research Protections within one month of becoming aware of the event on behalf of the University of Manitoba or applicable institution.
• Incomplete submissions/documents or submissions that do not meet the criteria listed above will not be processed and will be returned to the sender.
• Changes required to the protocol or consent form as a result of the unanticipated problem/ adverse event(s) must be submitted using the Bannatyne campus Amendment Form.
• Do not include a cover letter with the submission.

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.

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.

• 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 one electronic copy of the Bannatyne Campus EAE form for each file along with one electronic copy of the sponsor generated report within 15 days of becoming aware of the unanticipated EAEs.
• Submit via e-mail to bannreb@umanitoba.ca.
• Subject line of e-mail must be formatted as follows:
  • HS (REB#) – Non-Local Adverse Event Form
• Acknowledgment of receipt will not be issued. Retain your email to verify submission to the REB.
• 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.

Periodic safety update reports are sponsor-generated compilations of suspected unexpected serious adverse reactions (SUSARs) and/or other unanticipated problems that occurred during a particular reporting period (typically quarterly, semi-annual or annual), with a summary highlighting any main points of concern and the evolving safety profile of the investigational product.

Periodic safety update reports will be accepted provided:

• The report highlights the main points of concerns and the evolving safety profile of the investigational product.

• Upon receipt of the Periodic Safety Report from the sponsor, it is the investigator’s responsibility to review each report to ensure it meets the reporting criteria outlined above.
• Complete and submit two copies of the Bannatyne Campus External Adverse Event Form (EAE) for each file along with one copy of the sponsor-generated report within 15 days of becoming aware of the unanticipated EAEs. Include a self-addressed (postage attached for external mail) returned envelope.
• Incomplete submissions or 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 Summary Report will not be accepted.
• Changes required to the protocol or consent as a result of the adverse events outlined in the Periodic Safety Report must be submitted on the Bannatyne Campus Amendment Form.
• Do not include a cover letter with the submission.
• Faxed or email submissions are not accepted.

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

• Data Safety Monitoring (DSMB) 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

• Use this form to summarize and submit any updated safety information listed above.
• Do not use this form to accompany an Investigator’s Brochure for a new application.
• Complete and submit one electronic copy of the Bannatyne Campus Updated Safety Reporting Form for each file along with one electronic copy of the sponsor generated report.
• Submit via e-mail to bannreb@umanitoba.ca.
• Subject line of e-mail must be formatted as follows:
  • HS (REB#) –Updated Safety Report
• Acknowledgment of receipt will not be issued. Retain your email to verify submission to the REB.
• Submissions will not be accepted without completion of the Bannatyne Campus Updated Safety Reporting Form.
• Updated safety information which suggests increased risk and immediate safety concerns to participants should be reported to the REB promptly and no later than 15 days upon becoming aware of the information. All other updated safety information should be reported to the REB within 30 days of becoming aware of the report (e.g., DSMB report that suggest trial may continue as planned, New Investigators Brochure that does not require immediate notification of risks to participants, etc.)
• Any changes as result of the safety update information 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.