If the study uses a Pfizer drug, what are Pfizer’s procedures for reporting of Serious Adverse Events?
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.
Related Questions
- Are there special procedures for reporting adverse events? Researchers should review the Adverse Events FlowchartDoes ASU have any reciprocity agreements?
- 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?
