For REB Use Only
ST. MICHAEL’S RESEARCH ETHICS BOARD (REB)
EXTERNAL SERIOUS ADVERSE EVENT / UNANTICIPATED PROBLEM REPORTING FORM
See ‘Guidelines for Reporting Serious Adverse Events/Unanticipated Problems to the SMH REB’ and this Reporting Form at:
www.stmichaelshospital.com/research/reb.php
Complete this form and submit two (2) hard copies to the SMH REB.
Submissions that are incomplete will be returned to the submitter.
REB #:
Study Title:
SMH Principal Investigator:
Sponsor:
Definitions:
Adverse Event (AE): any unfavourable or unintended 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 research procedure(s) and which does
not necessarily have a causal relationship with the investigational product or any research procedure(s). An AE can therefore be any
unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally
associated with the use of an investigational product, whether or not related to the investigational product.
EXTERNAL (Non-Local) Adverse Event: An adverse event experienced by a research participant enrolled by the investigator(s) at
other centres outside the jurisdiction of the SMH REB. E.g. The research participant is enrolled at an external site in a multi-centre
trial in which SMH is also a participating site.
Serious Adverse Event (SAE) or Reaction: any untoward medical occurrence that:

results in death

is life-threatening

requires inpatient hospitalization or prolongation of existing hospitalization

results in persistent or significant disability/incapacity

results in a congenital anomaly/birth defect

based upon appropriate medical judgment, is an important medical event that may jeopardize the health of the research
participant or may require medical intervention to prevent one of the outcomes listed above.
Unanticipated Problem: any incident, experience, or outcome that meets ALL of the following criteria:

Unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocolrelated documents (e.g. the REB-approved research protocol and informed consent document, Investigator’s Brochure,
Product Monograph); and/or 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 event, 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.
Report ONLY individual external adverse events / unanticipated problems using this form.
SMH Investigator Assessment of EXTERNAL (Non-Local) SAE
YES
NO
Is this adverse event/unanticipated problem serious?
Is this adverse event/unanticipated problem unexpected?
Is this adverse event/unanticipated problem related or possibly related to the research?
Does this adverse event/unanticipated problem require a change to the study protocol and/or
consent form and/or require immediate notification to research participants for safety reasons?
If you answer “NO” to any of the above questions, report submission to the SMH REB is not required.
EXTERNAL Serious Adverse Event / Unanticipated Problem Reporting Form
Version Date: 09 July 2014
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ST. MICHAEL’S RESEARCH ETHICS BOARD (REB)
EXTERNAL SERIOUS ADVERSE EVENT / UNANTICIPATED PROBLEM REPORTING FORM
Date of Report (dd/mmm/yyyy) :
Study Status:(check all that apply)
Actively Enrolling
Closed to Enrollment
On Hold
Active Study Participants
Number of Participants Enrolled at SMH to Date:
Number of Participants Enrolled at all sites to Date:
Total Target Number of Participants:
Name of Adverse Event(AE) / Unanticipated Problem :
Type of Report:
Initial
Follow-Up
Final
If a follow-up or final report, please indicate the REB submission date(s) of previous report(s) (dd-mmm-yyyy) :
Participant Study ID #:
Age (years) at time of event:
Gender:
Start Date of Event (dd-mmm-yyyy):
Date SMH Study Team became
aware of Event (dd-mmm-yyyy):
SAFETY MONITORING
YES
NO
Is there an Independent Data Safety Monitoring Board (DSMB) for this study?
If yes, ensure all DSMB Meeting Summaries are submitted as per study protocol to the SMH REB using the Updated
Safety Information Reporting Form.
EXTERNAL Adverse Event (AE) / Unanticipated Problem *Any sponsor-generated reports related to this External Adverse
Event / Unanticipated Problem should be submitted with this report form.
Describe the External Adverse Event (AE) / Unanticipated Problem (including why it is considered an unanticipated
problem) Or
☐ included in the sponsor-generated report(s) attached.
Provide a description of all previous reports concerning similar events (including an analysis of significance of
the event in light of the previous reports) Or ☐ included in the sponsor-generated report(s) attached.
Description of the impact of the External Adverse Event(AE) / Unanticipated Problem on the study as a whole
and the impact (if any) at the local site (where the AE occurred) Or ☐ included in the sponsor-generated report(s)
attached.
EXTERNAL Serious Adverse Event / Unanticipated Problem Reporting Form
Version Date: 09 July 2014
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ST. MICHAEL’S RESEARCH ETHICS BOARD (REB)
EXTERNAL SERIOUS ADVERSE EVENT / UNANTICIPATED PROBLEM REPORTING FORM
SERIOUSNESS (outcome) of the Adverse Event(AE) / Unanticipated Problem:(check all that apply)
Resulted in Death
Life Threatening
Required In-patient hospitalization or prolonged existing hospitalization
Resulted in persistent or significant disability/incapacity
Caused congenital malformation/birth defect
Based upon appropriate medical judgement, is an important medical event that may jeopardize the health of the research
participant or may require medical intervention to prevent one of the outcomes listed above
RELATEDNESS of the Adverse Event(AE) / Unanticipated Problem
Possibly Related
Related / Probably Related
IMPACT ASSESSMENT
Does the Adverse Event (AE) / Unanticipated Problem require change(s) to the study protocol?
YES
NO
If yes, submit the changes using the ‘Amendment and Administrative Change Request Form’.
Does the Adverse Event (AE) / Unanticipated Problem require change(s) to the consent form(s)?
If yes, submit the changes using the ‘Amendment and Administrative Change Request Form’.
Should study participants be notified of this Adverse Event(AE) / Unanticipated Problem?
If no, please explain
Is this a reportable Serious Unexpected-Adverse Drug Reaction (SU-ADR) to Health Canada?
Principal Investigator / MD Co-Investigator Comments:
DECLARATION BY PRINCIPAL INVESTIGATOR / MD CO-INVESTIGATOR
I attest that I as the Principal Investigator (PI) or MD Co-Investigator (Co-I) have reviewed the Adverse Event(AE) / Unanticipated
Problem and its safety implications, assessed the relationship of the Adverse Event(AE) / Unanticipated Problem to the research
study and attest to the accuracy of this report.
I warrant that this study will continue to be conducted in accordance with the Tri-Council Policy Statement Ethical Conduct for
Research Involving Humans (TCPS), the Ontario Personal Health Information Protection Act (PHIPA) 2004, the St. Michael’s
Hospital By-laws, the Catholic Association of Canada Health Ethics Guide, and other relevant laws, regulations or guidelines, [e.g.,
Health Canada Part C, Division 5 of the Food and Drug Regulations, Part 4 of the Natural Health Products Regulations, Medical
Devices Regulations, and ICH/GCP Consolidated Guideline E6].
Printed Name of SMH Principal
Investigator
/ MD Co-Investigator
Signature
Date
TO BE COMPLETED BY THE RESEARCH ETHICS BOARD
I acknowledge that the St. Michael’s Hospital Research Ethics Board has reviewed the documents listed above.
Printed Name of REB Member
No further action required

Further action required
Signature
Date

EXTERNAL Serious Adverse Event / Unanticipated Problem Reporting Form
Version Date: 09 July 2014
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