Please provide a description of the serious adverse event ...



INSTRUCTIONS FOR REPORTING OF LOCAL and NON-LOCAL ADVERSE EVENTS DEFINITIONSInvestigational Product: Any drug, biologic, radiopharmaceutical, vaccine, natural health product, medical device or placebo being given to a research participantAdverse Event (AE): Any untoward medical occurrence in a research participant, administered investigational product, including an occurrence which does not have a causal relationship with the product. An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational productSerious Adverse Event (SAE): Is any adverse occurrence or response to a drug/intervention 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 aboveUnanticipated Problem: any incident, experience, or outcome (including an adverse event) that meets ALL of the following criteria:? *Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the HiREB-approved research protocol, informed consent document, and/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 [intervention(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.Note:*Unexpected: an event is “unexpected” when its specificity and severity are not accurately reflected in the HiREB-approved research protocol, the current HiREB-approved informed consent document, the Investigator Brochure, and/or other relevant sources of information; or when the event is not associated with the expected natural progression of any underlying disease, disorder, predisposing risk factor, or condition of the participant(s) experiencing the adverse event.+Related to the research procedures: an event is “related to the research procedures” if in the opinion of the Researcher or sponsor, the event was more likely than not to be caused by the research procedures.REPORTING LOCAL ADVERSE EVENTSAny local serious adverse event that in the opinion of Local Principal Investigator (LPI) is both unexpected and related or possibly related to, the study intervention or research procedures, must be reported to the HiREB. Please see definitions under “Unanticipated Problem” above. In the case of sponsored multi-site clinical trials, the LPI is unlikely to know if the SAE may pose a threat to other research participants at other sites; thus a local SAE must be reported if it satisfies the first 2 criteria of being unexpected and related/possibly related to, the study intervention.Use the Local Serious Adverse Event Report FormReport within 7 business days of becoming aware of the eventAll reports submitted to the HiREB must have all research participant identifiers removed (i.e., participant research ID number only)Once a local adverse event is acknowledged by the HiREB, subsequent important follow-up reports related to the adverse event should be submitted when available, as update(s)The reporting of SAEs may not be deferred to the Annual Progress ReportLocal SAEs must be reported by the LPI to the study sponsor and/or appropriate federal government agencies (eg. Health Canada)If the local site is part of a multi-centre study, the LPI must also append the most recent Data Safety Monitoring Board (DSMB) or a Sponsor-generated safety Report summarizing SAEs to date and any implications for the risk/benefit ratio, as described belowNOTE: The following local adverse events need NOT be reported to the HiREB:SAE that is expected and considered related to the investigational product or research proceduresSAE that is expected and considered not related to the investigational product or research proceduresSAE that is unexpected and is considered not related to the investigational product or research proceduresNon-serious AE which is expectedNon-serious AE which is unexpectedREPORTING OF LOCAL SERIOUS ADVERSE EVENT TO HiREBLOCAL SAEACTIONUnexpectedExpectedNot RelatedRelatedXXReport to HiREBXXNo Report to HiREBXXNo Report to HiREBXXNo Report to HiREBREPORTING NON-LOCAL SERIOUS ADVERSE EVENTSUpon receipt of a non-local adverse event, a periodic safety update, or safety summary report, the Local Principal Investigator must determine if it meets the HiREB reporting criteria:A Non-local Adverse Event is reportable to the HiREB, if in the opinion of the Local Principal Investigator, it meets the definition of an unanticipated problem AND requires a change to the research and/or informed consent form and/or requires immediate notification to participants for safety reasons. Please see definitions under “Unanticipated Problem” above.Use the Non-Local Serious Adverse Event Report FormThe report submitted to the HiREB must include all of the following information: The description of the unanticipated event(s)All previous safety reports concerning similar adverse eventsAn analysis of the significance of the current unanticipated event(s) in light of the previous reportsThe proposed research changes, informed consent form changes or other corrective actions to be taken by the sponsor in response to the event(s)The non-local individual SAE reports, periodic safety updates, or safety summary reports that meet the reporting criteria must be submitted to the HiREB within 15 business days of the Local Principal Investigator becoming aware of the event/report(s)Reports not meeting these requirements will be returned to the Local Principal InvestigatorDSMB and SPONSOR-GENERATED SAFETY REPORTSAll DSMB Reports must be forwarded to the HiREB within 15 business days of the Local Principal Investigator becoming aware of themThe DSMB report must be accompanied by a letter from the Local Principal Investigator indicating his/her acceptance of the findings and recommendations of the DSMBLOCAL SERIOUS ADVERSE EVENT REPORT?Use one form for each adverse event?Submit the Local Serious Adverse Event Report and any supporting documentsDate submitted to the REB: Click here to enter text.Local Principal Investigator: Click here to enter text.Contact Email: Click here to enter text.Contact Phone: Click here to enter text.Research Project Title: Click here to enter text.REB Project Number: Click here to enter text.Event Number: Click here to enter text.Initial ? or Follow-up Report ??Number Enrolled Locally to Date: Click here to enter text.Number Enrolled Study-wide to Date: Click here to enter text.TYPE OF EVENTCheck All That ApplyDeath?Life threatening?Hospitalization – initial or prolonged?Disability?Congenital deformity?Medically important event?Other – detail under “Description of AE” ?ADVERSE EVENT (Reporting is optional)Any untoward event which significantly affects subject well-being and does not fit above criteria of SAE?PARTICIPANT ID # OR REF # Click here to enter text.SEXClick here to enter text.DATE(S) OF THE EVENTClick here to enter text.AGEClick here to enter text.DESCRIPTION OF EVENT:Please provide a description of the serious adverse event below. Give the medical term of the event; describe the symptoms or event and the probable cause for the event, and the participant’s current medical status. Click here to enter text.CAUSALITYIn the opinion of the Local Principal Investigator, what is the relationship of the event to the study Related ?intervention? Check one onlyPossibly Related?See Naranjo Causality Scale page 4Other – Detail under “Description of Event”?ACTION TAKENCheck all that applyHospitalization – initial or prolonged?Study treatment altered (e.g. drug dose changed)?Study treatment stopped (e.g. drug stopped or device removed)?Study blind broken?Other – detail under “Description of Event”?OUTCOMECheck all that applyComplete resolution?Ongoing/Unresolved?Partial recovery?Disability or impairment (permanent)?Disability or impairment (may improve with time)?Death?Other – detail under “Description of Event”?Did the participant remain in the study on protocol?Yes?No?If NO, is the participant’s clinical status being monitored?Yes?No?In the opinion of the Local Principal Investigator, does the event warrant…Continuation of the study?Yes?No?Changes to study procedures and protocol?(If YES, submit an Amendment Request)Yes?No?Revisions to Information/Consent documents?(If YES, submit an Amendment Request)Yes?No?Attach the most recent Data Safety Monitoring Board (DSMB) Report or forward a Sponsor-generated analysis of Serious Adverse Events to-date (if applicable)Attached?To follow?___________________________________________________Signature of Local Principal Investigator(A designate signature will not be accepted)___________________________________________________DateLOCAL SERIOUS ADVERSE EVENT REPORT(This box to be completed by the LPI)Local Principal Investigator: Click here to enter text.HiREB Project #: Click here to enter text. Title of Study: Click here to enter text.Event #: Click here to enter text.REVIEW BY HiREB CHAIR? Further review is NOT required by the HiREB_____________________________________________________________________Signature of HiREB Chair DateSubmit one (1) copy of the Local Serious Adverse Event Report and supporting documentation to the HiREB at the address noted below Please complete the scale below prior to sending the form.Hamilton Integrated Research Ethics BoardSuite 102—293 Wellington Street NorthHamilton, ON L8L 8E7For assistance contact the Research Ethics Officer at 905-521-2100 x 44574In assigning Adverse Event Reaction causality, please use the Naranjo scale belowStep 1: To assess relatedness of the adverse reaction to a drug / device / study procedure (intervention), answer the following questions to determine the pertinent score(s). In the score column, indicate the value associated with your answer of “yes” or “no” to each question. Add the scores to arrive at a total score.Please answer the following questions:YesNoDo NotKnowScore1. Are there any previous reports from any source on this reaction indicating possible, probably or definite relationship to drug/device/procedure (intervention) required by the protocol?+100Click here to enter text.2. Did the adverse event appear after the suspected drug/device/intervention was administered?+2-10Click here to enter text.3. Did the adverse reaction improve when thedrug/device/intervention was discontinued, or a specific antagonist was administered?+100Click here to enter text.4. Did the adverse reaction reappear when the drug/device/intervention was re-administered?+2-10Click here to enter text.5. Are there alternative causes (other than the drug/device/intervention) that could on their own have caused the reaction?-1+20Click here to enter text.6. Did the reaction reappear when a placebo was given?-1+10Click here to enter text.7. Was the drug/device detected in the blood (or other fluids) in concentrations known to be toxic?+100Click here to enter text.8. Was the reaction more severe when the dose was increased, or less severe when the dose was decreased?+100Click here to enter text.9. Did the patient have a similar reaction to the same or similar drug/device/intervention in any previous exposure?+100Click here to enter text.10. Was the adverse event confirmed by objective evidence?+100Click here to enter text.11. Total Score:Click here to enter text.Step 2: Assign the probability of relatedness. Based on the value of the total score, check the appropriate box below:? Definitely Related (Score ≥ 9)? Probably Related (Score 5-8)? Possibly Related (Score 1-4)? Doubtful/Unknown Relationship (Score ≤0)If you did not check any of the criteria above – or checked either “Possibly Related” or “Doubtful/Unknown Relationship” – then the event is considered NOT “related” to study product / intervention.Was the event related to study product/intervention? (Did you check either “Definitely Related” or “Probably Related” above) ? Yes ? No ................
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