For REB Use Only
ST. MICHAEL’S RESEARCH ETHICS BOARD (REB)
LOCAL 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: http://stmichaelshospitalresearch.ca/staff-services/research-ethics/forms-guidelines/
Complete this form and submit three (3) 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.
LOCAL (Internal) Adverse Event: An adverse event experienced by a research participant enrolled by the investigator(s) at one or
more centres under the jurisdiction of the SMH REB (REB of Record). In the context of a single-centre clinical trial, all adverse
events would be considered local adverse events.
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 local adverse events / unanticipated problems using this form.
SMH Investigator Assessment of LOCAL (Internal) SAE
YES
NO
Is this adverse event/unanticipated problem serious?
Is this adverse event/unanticipated problem unexpected?
Is there a reasonable possibility* that this adverse event/unanticipated problem may be related
to the research? (* A reasonable possibility means that a causal relationship cannot be ruled out.)
If you answer “NO” to any of the above questions, report submission to the SMH REB is not required.
LOCAL Serious Adverse Event / Unanticipated Problem Reporting Form
Version Date: 24-Nov-2015
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ST. MICHAEL’S RESEARCH ETHICS BOARD (REB)
LOCAL 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:
Follow-Up
Initial
Final
If a follow-up or final report, please indicate the REB submission date(s) of previous report(s) (dd-mmm-yyyy) :
Age (years) at time of event:
Gender:
Participant Study ID #:
Start Date of Event (dd-mmm-yyyy):
Date SMH Study Team became aware of
Event (dd-mmm-yyyy):
Describe the Adverse Event(AE) / Unanticipated Problem (including why it is considered an unanticipated problem;
concomitant illness; past medical history; medications; relevant test results, etc.).
Describe the research team’s response to the event.
Participant’s outcome of the event (if known).
SERIOUSNESS (outcome) of the Adverse Event(AE) / Unanticipated Problem:(check all that apply)
Resulted in Death
Life Threatening
Required In-patient hospitalization or prolonged exisiting 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
Related / Probably Related
Possibly Related
LOCAL Serious Adverse Event / Unanticipated Problem Reporting Form
Version Date: 24-Nov-2015
Unlikely
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ST. MICHAEL’S RESEARCH ETHICS BOARD (REB)
LOCAL SERIOUS ADVERSE EVENT / UNANTICIPATED PROBLEM REPORTING FORM
SAFETY MONITORING
YES
NO
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.
IMPACT ASSESSMENT
Does the Adverse Event(AE) / Unanticipated Problem require change(s) to the study
protocol? 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

LOCAL Serious Adverse Event / Unanticipated Problem Reporting Form
Version Date: 24-Nov-2015
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