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Serious Adverse Event Reporting

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

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Serious Adverse Event Reporting

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

  2. Procedures • Using Pfizer Products • MUST follow Pfizer SAE reporting policies

  3. 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

  4. When to report: UNEXPECTED An event that is not expected due to the progression of underlying disease or co-morbid illnesses.

  5. SAE Reports to: Pfizer Canada Drug Safety Group AND Acopy sent to CERU Project Leader SAE Manual pg. 7

  6. 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 28 days 14 days Report all SAEs to Pfizer & CERU SAE Manual pg. 6

  7. 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

  8. SAE Report Forms SAE Manual, Appendix A & B

  9. Minimum required information 1. Identifiable Patient

  10. Minimum required information 2. Suspect Product

  11. Minimum required information 3. SAE (diagnosis or signs & symptoms)

  12. Minimum required information 4. Identifiable reporting source

  13. 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 • Comorbidities • Study procedures • Other NO SAE Manual pg. 7

  14. 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

  15. Site identifies a reportable SAE Site reports SAE to local REB as per local requirements Site completes an initial report using Pfizer SAE Report Form • 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. Sends report to: Pfizer AND CERU YES Causally related to IP? YES & NO Pfizer will correspond with site until report is complete CERU will send completed report to all participating sites. Site to submit to local REB.

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

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