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Serious Adverse Event Reporting Start-up Meeting March 25, 2010 Kingston, ON Procedures Using Pfizer Products MUST follow Pfizer SAE reporting policies SAEs Defined Any untoward medical occurrence that at any dose results in: Death Is life-threatening Requires in-patient hospitalization or prolongs hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly or birth defect An important medical event SAE Manual pg. 4-5 When to report: Reportable (x) SAE Criteria Death Expected Unexpected x x Life-threatening x UNEXPECTED Hospitalization x An event that is not expected due to the progression of underlying disease or co-morbid illnesses. Disability/Incapacity x Congenital anomaly, birth defect Important medical event x x SAE Reports to: Pfizer Canada Drug Safety Group AND A copy sent to CERU Project Leader SAE Manual pg. 7 Reporting Timelines From the time the patient receives the first dose until 28 days following the last dose Last Dose of Investigational Product Consent Obtained 28 days post last dose of IP Randomization 14 days 28 days Report all SAEs to Pfizer & CERU SAE Manual pg. 6 Initial Reports - Timing Fatal & Life-threatening: IMMEDIATELY All other SAEs: within 24 hours of awareness of the occurrence of the event SAE Manual pg. 6 SAE Report Forms SAE Manual, Appendix A & B Minimum required information 1. Identifiable Patient Minimum required information 2. Suspect Product Minimum required information 3. SAE (diagnosis or signs & symptoms) Minimum required information 4. Identifiable reporting source Causality Assessment A determination of whether or not there is a reasonable possibility that the blinded therapy is caused or contributed to the SAE. YES OR •Concomitant medications •Background treatment NO •Comorbidities •Study procedures •Other SAE Manual pg. 7 Follow-up Information New, updated or corrected information to a previously submitted report: Missing or incomplete info at time of initial report Info not previously available Changes or clarifications Additional information as requested by Pfizer or CERU Site identifies a reportable SAE Site completes an initial report using Pfizer SAE Report Form If event is casually related to IP, CERU must report to Health Canada: Sends report to: Pfizer AND CERU YES Causally related to IP? YES & NO Pfizer will correspond with site until report is complete Site reports SAE to local REB as per local requirements •Death or Life-threatening = 7 calendar days •All other SAEs = 15 calendar days CERU will correspond with the site until report is complete. CERU will send completed report to all participating sites. Site to submit to local REB. Unblinding There is no known antidote for the investigational products If there are concerns regarding the investigational product, stop the product and complete a Protocol Violation Form If unblinding is required procedures outlined SAE Manual pg. 9