If the study uses a Pfizer drug, what are Pfizer’s procedures for reporting of Serious Adverse Events (SAEs)?

If the study uses a Pfizer drug, what are Pfizer’s procedures for reporting of Serious Adverse Events?
Reporting of Serious Adverse Events is a key responsibility of the Research Award Principal Investigator. (top)



For All Studies Using a Pfizer Product and/or Device: Pfizer requires that, within 24 hours of first awareness of the event (or immediately if the event is fatal or life-threatening), the principal investigator will report to Pfizer by facsimile any Serious Adverse Event (SAE) that occurs during the SAE reporting period in a study subject assigned to receive the Pfizer Product. In addition, for studies using a Pfizer device or Pfizer product packaged with a device, reportable events include not only SAEs but also Device Incidents and Device Near-Incidents.
  • Reporting Forms: The principal investigator will report such SAEs using the Pfizer IIR SAE reporting form or the approved local regulatory form (i.e., FDA MEDWATCH form, CIOMS, etc.) and the Reportable Event Fax Cover Sheet provided by Pfizer. SAEs should be reported as soon as they are determined to meet the definition, even if complete information is not yet available.
  • Reporting Period: The Reportable Events that are subject to this provision are those that occur from after the first dose of the Pfizer product through 28 days after discontinuation of the Pfizer product.
  • Follow-up Information: The institution and/or principal investigator will assist Pfizer in investigating any SAE and will provide any follow-up information reasonably requested by Pfizer.
  • Regulatory Reporting: Reporting an SAE to Pfizer does not relieve the institution and/or principal investigator of the responsibility for reporting it to the FDA or local regulatory authority, as required. (top)

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