Serious adverse event notification form



Unity Health Toronto Research Ethics Board (Unity Health REB)Local Serious Adverse Event / Unanticipated Problem Reporting FormThis form is to be used to report Serious Adverse Events (SAEs) and Unanticipated Problems that occurred at any Unity Health site: Providence Healthcare (PHC), St. Joseph’s Health Centre (SJHC), and St. Michael’s Hospital (SMH).Do not include this page with your submission.See ‘Guidelines for Reporting Serious Adverse Events/Unanticipated Problems to the REB’ at: 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 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 deathis life-threateningrequires inpatient hospitalization or prolongation of existing hospitalizationresults in persistent or significant disability/incapacityresults in a congenital anomaly/birth defectbased 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 protocol-related 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; andRelated 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); andSuggests 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.For REB Use OnlyForm Version Nov 2019Unity Health Toronto Research Ethics Board (Unity Health REB)Local Serious Adverse Event / Unanticipated Problem Reporting FormComplete this form electronically (i.e. not handwritten) and submit two (2) signed hard copies to the REB.Note: In this form, Providence Healthcare is referred to as “PHC”, St. Joseph’s Health Centre as “SJHC”, and St. Michael’s Hospital as “SMH”Report ONLY local adverse events / unanticipated problems using this form.REB #: FORMTEXT ?????Study Title: FORMTEXT ?????Unity Health Lead Applicant: FORMTEXT ?????Sponsor: FORMTEXT ?????Assessment of Unity Health LOCAL SAEIf you answer “NO” to any of the questions, submission to the REB is not required.YESNOIs 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.??Unity Health SitesPHCSJHCSMHAt which Unity Health site is the participant enrolled????Which Unity Health sites are involved in this study????Study StatusOverall Study Status: ?Not Started ?Active ?On Hold ?Data Analysis OnlyEnrollment Status: ?Enrollment Not Started ?Enrollment Ongoing ?Enrollment CompleteAre there currently active study participants? ?Yes ?Follow-up Only ?NoNumber of Participants Enrolled at all Unity Health Toronto sites to Date: FORMTEXT ?????Number of Participants Enrolled at all external sites to Date: FORMTEXT ?????Total Target Number of Participants: FORMTEXT ?????Report InformationDate of Report (dd/mmm/yyyy): FORMTEXT ?????Type of Report:? Initial ? Follow-up? FinalIf a follow-up or final report, please indicate the REB submission date(s) of previous report(s) (dd-mmm-yyyy): FORMTEXT ?????, FORMTEXT ?????, FORMTEXT ?????Participant InformationParticipant Study ID #: FORMTEXT ?????Age (years) at time of event: FORMTEXT ?????Gender: FORMTEXT ?????Event InformationName of Adverse Event (AE) / Unanticipated Problem: FORMTEXT ?????Start Date of Event (dd-mmm-yyyy): FORMTEXT ?????Date Study Team became aware of Event (dd-mmm-yyyy): FORMTEXT ?????Describe the Adverse Event(AE) / Unanticipated Problem:Include why it’s considered an unanticipated problem; any concomitant illness; medical history; current medications; relevant test results, etc. Attach the completed sponsor’s serious adverse event (SAE) form (if applicable). FORMTEXT ?????Describe the study team’s response to the event. FORMTEXT ????? Participant’s outcome of the event (if known). FORMTEXT ?????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 aboveRELATEDNESS of the Adverse Event (AE) / Unanticipated Problem?Related / Probably Related?Possibly Related?UnlikelySafety MonitoringIs 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 REB using the ‘Updated Safety Information Reporting Form’.?Yes?NoImpact AssessmentDoes the Adverse Event(AE) / Unanticipated Problem require change(s) to the study protocol?If yes, submit the changes using the ‘Amendment Request Form’.?Yes?NoDoes the Adverse Event(AE) / Unanticipated Problem require change(s) to the consent form(s)?If yes, submit the changes using the ‘Amendment Request Form’.?Yes?NoShould study participants be notified of this Adverse Event (AE) / Unanticipated Problem?If no, please explain: FORMTEXT ??????Yes?NoIs this a reportable Serious Unexpected-Adverse Drug Reaction (SU-ADR) to Health Canada??Yes?NoSite Investigator Comments (to be completed by the Site Investigator at the Site where the SAE occurred)DECLARATION BY SITE INVESTIGATORAs the Site Investigator, I attest that I have reviewed the Adverse Event(AE) / Unanticipated Problem 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 (TCPS2), the Ontario Personal Health Information Protection Act (PHIPA) 2004, Unity Health Toronto 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 Site InvestigatorSignature**Original ink or authenticated electronic/digital signature (copy/pasted images of scanned signatures are not acceptable)DateFOR REB OFFICE USE ONLY No further action required Further Action Required (select all that apply, and explain): Protocol change Consent Form change Follow up report OtherExplain:Full Board Review? Yes NoOther Comments:Printed Name of REB Chair or designeeSignatureDate ................
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