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

Reporting of Serious Adverse Events. Within 24 hours of first awareness of the event (immediately if the event is fatal or life-threatening), Principal Investigator will report to Pfizer by facsimile any Serious Adverse Event (“SAE,” as defined below) for which reporting is required under this provision (as described below). Such SAEs are to be reported for (1) Study subjects who are assigned or, in the case of a blinded Study, possibly assigned to receive the Pfizer Product or (2) individuals otherwise exposed to the Pfizer Product as described below. Principal Investigator should report SAEs as soon as they are determined to meet the definition, even if complete information is not yet available.


  1. Reporting Forms. Principal Investigator will report SAEs using one of the following forms: (1) a reporting form approved by the local regulatory authority, (2) a CIOMS form, (3) a Pfizer-provided Investigator-Initiated Research Serious Adverse Event Form, or (4) any other form prospectively approved by Pfizer. The Reportable Event Fax Cover Sheet provided by Pfizer must also be included with each SAE submitted.
  2. SAE Definition. An SAE is any adverse event, without regard to causality, that is life-threatening (i.e., causes an immediate risk of death) or that results in any of the following outcomes: death; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity (i.e., substantial disruption of the ability to conduct normal life functions); or a congenital anomaly or birth defect. Any other medical event that, in the medical judgment of the Principal Investigator, may jeopardize the subject or may require medical or surgical intervention to prevent one of the outcomes listed above is also considered an SAE. A planned medical or surgical procedure is not, in itself, an SAE
  3. Exposure During Pregnancy, Exposure During Lactation, Occupational Exposure, and Lack Of Effect. Even though there may not be an associated SAE, exposure to the Pfizer Product during pregnancy, exposure to the Pfizer Product during lactation, and occupational exposure to the Pfizer Product are reportable, and lack of effect of the Pfizer Product may also be reportable. These requirements are further explained in the training material provided by Pfizer (see Pfizer-Provided Training, below). As used in this Agreement, the term SAE will be understood to include exposure during pregnancy, exposure during lactation, occupational exposure, and reportable instances of lack of effect.
  4. Hy’s Law Cases. Cases of potential drug-induced liver injury as assessed by laboratory test values (“Hy’s Law Cases”) are also reportable to Pfizer. If a Study subject develops abnormal values in aspartate transaminase (AST) or alanine transaminase or both, concurrent with abnormal elevations in total bilirubin and no other known cause of liver injury, that event would be classified as a Hy’s Law Case. This reporting requirement is further explained in the training material provided by Pfizer (see Pfizer-Provided Training, below). As used in this Agreement, the term SAE will be understood to also include Hy’s Law Cases.
  5. Exclusions from SAE Reporting Requirements. Specifically excluded from the reporting requirements for SAEs under this provision is any SAE identified in the Protocol as anticipated to occur in the Study population at some frequency independent of drug exposure, unless the Principal Investigator assesses such an event as related to the Pfizer Product.
  6. SAE Reporting Period. The SAEs that are subject to this reporting provision are those that occur from after the first dose of the Pfizer Product through 28 calendar days after the last administration of the Pfizer Product, or longer if so specified in the Protocol. In addition, if Principal Investigator becomes aware of an SAE occurring any time after the administration of the last dose of the Pfizer Product, Principal Investigator should report that SAE to Pfizer if the Principal Investigator suspects a causal relationship between the Pfizer Product and the SAE.
  7. Follow-Up Information. Principal Investigator will assist Pfizer in investigating any SAE and will provide any follow-up information reasonably requested by Pfizer.
  8. Regulatory Reporting. Reporting an SAE to Pfizer does not relieve Principal Investigator of responsibility for reporting it to appropriate regulatory authorities, if such reporting is required.
  1. Pfizer-Provided Training. Pfizer will make available training material that provides information about the SAE reporting requirements for IIR studies. Principal Investigator will review this material and share it with any Study staff engaged in the reporting of SAEs.

In addition, for any non-interventional study with sites in the EU, the following requirements also apply:
Reporting of Non-Serious Adverse Events. Certain Non-Serious Adverse Events (“NS-AEs,” as defined below) must also be reported to Pfizer. The NS-AEs that are reportable to Pfizer are those that (1) were specified in the Protocol as being reportable and (2) occur during the NS-AE reporting period (as defined below). Within 24 hours of first awareness of the event, Principal Investigator will report to Pfizer by facsimile any such NS-AE. Principal Investigator should report these NS-AEs as soon as they are determined to meet the definition and reportability criteria, even if complete information is not yet available.



  1. Reporting Forms. Principal Investigator will report NS-AEs on one of the following forms: (1) a reporting form approved by the local regulatory authority, (2) a CIOMS form, (3) a Pfizer-provided Investigator-Initiated Research Non-Interventional Study Adverse Event Report Form, or (4) any other form prospectively approved by Pfizer. The Reportable Event Fax Cover Sheet provided by Pfizer must also be included with each NS-AE submitted.
  2. AE and NS-AE Definitions. An Adverse Event (“AE”) is any untoward medical occurrence in a Study subject receiving the Pfizer Product or an individual otherwise exposed to the Pfizer Product, without regard to whether there is a causal relationship between the Pfizer Product and the medical occurrence. A Non-Serious AE (“NS-AE”) is any AE that does not meet the definition of an SAE (see Section 3.7.b, SAE Definition). For this Study, only NS-AEs identified in the Study Protocol as reportable must be submitted to Pfizer.
  3. NS-AE Reporting Period. Unless the Protocol specifies a longer period, the NS-AEs that are subject to this reporting provision are those that occur from after the first dose of the Pfizer Product or the Study subject’s enrolment in the Study (whichever is later) through 28 calendar days after the last administration of the Pfizer Product or the subject’s last Study visit (whichever is earlier).
  4. Follow-Up Information. Institution will assist Pfizer in investigating any NS-AE if Pfizer considers it necessary and will provide any follow-up information reasonably requested by Pfizer.
  5. Regulatory Reporting. Reporting an NS-AE to Pfizer does not relieve Institution of responsibility for reporting it to appropriate regulatory authorities, if such reporting is required.
  6. Pfizer-Provided NS-AE Training. Further information about the NS-AE reporting requirements for non-interventional IIR studies conducted within the European Union is provided in the Pfizer-provided training referenced in Section 3.7, above. Principal Investigator will review this material and share it with any Study staff engaged in the reporting of NS-AEs. (top)

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