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