Retrospective Studies Sample Clauses

Retrospective Studies. SAEs/NS-AEs that are subject to the reporting requirements in retrospective studies are those that are identified though the medical chart review as defined per the patient population and study period specified in the protocol. These reporting requirements are for those SAEs/NS-AEs for which there is an explicit attribution to the Pfizer product documented by the treating healthcare professional in the medical chart. Explicit attribution is not inferred by a temporal relationship between drug administration and an AE but must be based on a definite statement of causality by a healthcare provider linking drug administration to the AE.