Research Ethics Board (REB)
Guidelines for Reporting an Internal Serious Adverse Event (SAE)
DEFINITIONS
Adverse Event (AE)
Any unfavourable or unintended medical occurrence or change in current health status in a subject
participating in a research study. An AE may also be referred to as an Adverse Reaction, Adverse
Experience, or Side Effect. An Adverse Drug Reaction (ADR) specifically refers to an AE for which a
causal relationship between the product/device is at least a reasonable possibility, (i.e. the
relationship cannot be ruled out).
Causality
The relationship between an adverse event and the test agent in terms defined by the protocol (i.e.
unrelated, unlikely related, possibly related, probably related, related).
Serious Adverse Event (SAE)
Any untoward medical occurrence that at any dose:
 results in death,
 is life-threatening,
 requires inpatient hospitalization or prolongation of existing hospitalization,
 results in persistent or significant disability/incapacity, or
 is a congenital anomaly/defect.
An occurrence is also considered an SAE when:
 there is an increase in the rate of occurrence of an expected SAE, or
 it poses a significant hazard to the research participant or the patient population
Medical or scientific judgement should be exercised in deciding whether expedited reporting is
appropriate in other situations, such as important medical events that may not be immediately lifethreatening or result in death or hospitalization but may jeopardize the patient or may require
intervention to prevent one of the other outcomes listed in the definition above. These should also
usually be considered serious.
Internal SAE
Any serious adverse event that occurs with a Sunnybrook study participant.
REGULATORY REQUIREMENTS
Submission to Health Canada
Only adverse drug reactions that are both serious and unexpected are subject to expedited reporting
to Health Canada. Expedited reporting of reactions which are serious but expected is not required.
Expedited reporting is also inappropriate for serious events from clinical investigations that are
considered unrelated to the study product, whether or not the event is expected.
During a clinical trial the sponsor is required to inform Health Canada of any serious, unexpected
adverse drug reaction that has occurred inside or outside Canada:
Version Date: 06 February 2012
Page 1 of 2
Sunnybrook Health Sciences Centre REB – 2075 Bayview Avenue, Room C819, Toronto ON M4N 3M5
Tel: 416-480-6100 ext. 4276 or 88144 Fax: 416-480-5385 www.sunnybrook.ca
1. where it is neither fatal nor life-threatening, within 15 days after becoming aware of the
information;
2. where it is fatal or life-threatening, immediately where possible and, in any event, within 7 days
after becoming aware of the information; and
3. within 8 days after having informed Health Canada of the ADR, submit as complete a report as
possible which includes an assessment of the importance and implication of any findings.
Each ADR which is subject to expedited reporting should be reported individually in accordance with
the data element(s) specified in the Health Canada / ICH Guidance Document E2A: Clinical Safety
Data Management: Definitions and Standards for Expedited Reporting.
REPORTING REQUIREMENTS

Internal SAEs must be reported to the REB providing all available information as soon as the first
member of the study team is aware of the event.

Submit a follow-up report within 10 calendar days of the date the first member of the study team
became aware of the event to provide new information obtained since submission of the initial
report or confirm that there is no new information to report. Subsequent follow-up reports must be
submitted as they occur, up to and including, the final report. It is the responsibility of the PI to
ensure subsequent reports are submitted to the REB as they occur.

Internal SAEs must be submitted using the Sunnybrook REB Internal SAE Reporting Form.

When completing the Sunnybrook REB Internal SAE Reporting Form, do not reference “the
attached report”. Sponsor specific SAE Forms may be attached as supporting documentation.

The form must include an original signature.

If the study action recommended (as indicated on the form) requires any changes to the study,
submit relevant documents under separate cover using the Sunnybrook REB Amendments,
Notifications, Ongoing Communications Form.

The REB procedure for reporting internal SAEs supersedes any other time frame specified in a
research protocol.

The REB has no regulatory obligation to acknowledge receipt of internal SAEs, however, all will be
acknowledged. It is the responsibility of the sender to retain proof of submission.
REFERENCES
 Health Canada, Guidance for Industry, Good Clinical Practice: Consolidated Guideline, ICH Topic
E6, 1997.
 Health Canada, Guidance for Industry, Clinical Safety Data Management: Definitions and
Standards for Expedited Reporting, ICH Topic E2A, 1995.
 Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 2nd Edition (TCPS
2), 2010.
 University Health Network Procedure for Reporting Adverse Events in Research Studies Involving
Human Subjects, Revised: October 25, 2006.
 Mount Sinai Hospital Research Ethics Board Adverse Event Reporting in Research Studies
Involving Human Subjects, Policy #1.01, Revised: October 1, 2004.
Version Date: 06 February 2012
Page 2 of 2
Sunnybrook Health Sciences Centre REB – 2075 Bayview Avenue, Room C819, Toronto ON M4N 3M5
Tel: 416-480-6100 ext. 4276 or 88144 Fax: 416-480-5385 www.sunnybrook.ca