Serious Adverse Event Reporting Start-up Meeting March 25, 2010 Kingston, ON.

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Presentation transcript:

Serious Adverse Event Reporting Start-up Meeting March 25, 2010 Kingston, ON

Procedures Using Pfizer Products Using Pfizer Products MUST follow Pfizer SAE reporting policies MUST follow Pfizer SAE reporting policies

SAEs Defined Any untoward medical occurrence that at any dose results in: Any untoward medical occurrence that at any dose results in: Death Death Is life-threatening Is life-threatening Requires in-patient hospitalization or prolongs hospitalization Requires in-patient hospitalization or prolongs hospitalization Results in persistent or significant disability/incapacity Results in persistent or significant disability/incapacity Is a congenital anomaly or birth defect Is a congenital anomaly or birth defect An important medical event An important medical event SAE Manual pg. 4-5

When to report: SAE Criteria Reportable (x) ExpectedUnexpected Deathxx Life-threateningx Hospitalizationx Disability/Incapacityx Congenital anomaly, birth defect x Important medical eventx UNEXPECTED An event that is not expected due to the progression of underlying disease or co-morbid illnesses.

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 From the time the patient receives the first dose until 28 days following the last dose SAE Manual pg. 6 Consent Obtained Last Dose of Investigational Product Randomization 28 days post last dose of IP 28 days Report all SAEs to Pfizer & CERU 14 days

Initial Reports - Timing Fatal & Life-threatening: IMMEDIATELY Fatal & Life-threatening: IMMEDIATELY All other SAEs: within 24 hours of awareness of the occurrence of the event 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. OR Concomitant medications Background treatment Comorbidities Study procedures Other YES NO SAE Manual pg. 7

Follow-up Information New, updated or corrected information to a previously submitted report: New, updated or corrected information to a previously submitted report: Missing or incomplete info at time of initial report Missing or incomplete info at time of initial report Info not previously available Info not previously available Changes or clarifications Changes or clarifications Additional information as requested by Pfizer or CERU Additional information as requested by Pfizer or CERU

Site completes an initial report using Pfizer SAE Report Form Sends report to: Pfizer AND CERU Site identifies a reportable SAE Site reports SAE to local REB as per local requirements Pfizer will correspond with site until report is complete If event is casually related to IP, CERU must report to Health Canada: Death or Life-threatening = 7 calendar days All other SAEs = 15 calendar days CERU will correspond with the site until report is complete. Causally related to IP? YES & NO YES CERU will send completed report to all participating sites. Site to submit to local REB.

Unblinding If there are concerns regarding the investigational product, stop the product and complete a Protocol Violation Form If there are concerns regarding the investigational product, stop the product and complete a Protocol Violation Form If unblinding is required procedures outlined If unblinding is required procedures outlined SAE Manual pg. 9 There is no known antidote for the investigational products