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Abstract

As the number of patient registries for marketed products increases, it is important for investigators and manufacturers to understand the public health responsibilities and potential regulatory requirements for reporting adverse drug events (AEs). Requirements for reporting AEs will vary depending upon sponsorship of the registry (regulated versus non-regulated industry). If registries are sponsored or supported by a regulated entity and AEs are noted in the course of a registry's direct patient contact concerning a marketed drug product, the seriousness, expectedness, and possible relationship of the AE to the drug product should be assessed. Recommendations are presented for good registry practices for detecting, processing, and reporting adverse events.

Keywords

Registries Adverse event reporting SAE

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Good Practices for Handling Adverse Events Detected through Patient Registries

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