Serious adverse event notification form

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Unity Health Toronto Research Ethics Board (Unity Health REB)External Serious Adverse Event / Unanticipated Problem Reporting FormThis form is to be used to report Serious Adverse Events (SAEs) and Unanticipated Problems that occurred outside of the jurisdiction of the Unity Health REB. i.e. For SAEs experienced by a research participant enrolled at an external site in a multi-centre trial in which a Unity Health site is a participating site.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.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 REB. E.g. The research participant is enrolled at an external site in a multi-centre trial in which a Unity Health site is also a participating site.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)External 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 individual external adverse events / unanticipated problems using this form.REB #: FORMTEXT ?????Study Title: FORMTEXT ?????Unity Health Lead Applicant: FORMTEXT ?????Sponsor: FORMTEXT ?????Unity Health Lead Applicant Assessment of EXTERNAL (Non-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.??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???Is a Unity Health site (PHC, SJHC or SMH) participating in the trial in which the adverse event/unanticipated problem occurred???Which Unity Health Toronto sites are involved in this study?? Providence Healthcare ? St. Joseph’s Health Centre? St. Michael’s HospitalStudy 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 ?????EXTERNAL Adverse Event or Unanticipated Problem InformationAny sponsor-generated reports related to this External Adverse Event / Unanticipated Problem should be submitted with this form.Name 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 External Adverse Event(AE) / Unanticipated Problem (including why it is considered an unanticipated problem)Or ?This information is included in the attached sponsor-generated report(s). FORMTEXT ?????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 ?This information is included in the attached sponsor-generated report(s). FORMTEXT ?????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 ? This information is included in the attached sponsor-generated report(s) 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?NoUnity Health Lead Applicant or MD Co-Investigator CommentsDECLARATION BY THE UNITY HEALTH LEAD APPLICANT OR MD CO-INVESTIGATORI attest that I as the Unity Health Lead Applicant or MD Co-Investigator (Co-I) 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 Unity Health Lead Applicant or MD Co-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 No Other Comments:Printed Name of REB Chair or designeeSignatureDate ................
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