<p> Research Ethics Board (REB) Guidelines for Reporting an Internal Serious Adverse Event (SAE)</p><p>Sunnybrook REB Internal SAE Reporting Criteria </p><p>The REB requires submission of local serious adverse events that meet the following criteria ONLY:</p><p> Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-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.</p><p>DEFINITIONS</p><p>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).</p><p>Internal Adverse Event Internal adverse events are those experienced by research participants enrolled by the investigator(s) at one or more centres under the jurisdiction of the Sunnybrook REB.</p><p>Serious Adverse Event (SAE) 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, or . is a congenital anomaly/defect.</p><p>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</p><p>REGULATORY REQUIREMENTS</p><p>Submission to Health Canada Only adverse 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.</p><p>Version Date: 28 July 2015 Page 1 of 3</p><p>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 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.</p><p>During a clinical trial the sponsor is required to inform Health Canada of any serious, unexpected adverse reaction that has occurred inside or outside Canada:</p><p>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. </p><p>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.</p><p>PROCESS FOR REPORTING TO THE REB</p><p>. The REB expects all related or possibly related and unexpected internal SAEs to be provided within 15 calendar days of the principal investigator becoming aware of the event. Fatal or life- threatening internal SAEs should be reported to the REB within 7 calendar days</p><p>. Follow-up reports of the SAE should be submitted to the REB when there is new relevant information about the SAE. It is the responsibility of the PI to ensure subsequent and final report(s) are submitted to the REB.</p><p>. Internal SAEs must be submitted using the Sunnybrook REB Internal SAE Reporting Form.</p><p>. 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.</p><p>. 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.</p><p>. The REB procedure for reporting internal SAEs supersedes any other time frame specified in a research protocol.</p><p>. 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. </p><p>REFERENCES</p><p>. 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), 2014.</p><p>Version Date: 28 July 2015 Page 2 of 3</p><p>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 . Canadian Association of Research Ethics Boards (CAREB) Guidance on Reporting of Unanticipated Problems including Adverse Events to Research Ethics Boards in Canada, July 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.</p><p>Version Date: 28 July 2015 Page 3 of 3</p><p>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</p>