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Developmental Safety Update Report (DSUR) – Why and when to submit?

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Mastering the Developmental Safety Update Report (DSUR)

The Developmental Safety Update Report (DSUR) is the standard for safety reporting during the clinical trial phase of drug development. Its purpose is to provide a comprehensive annual review and evaluation of relevant safety information collected during the reporting period.

When to Submit a Developmental Safety Update Report

A Developmental Safety Update Report must be submitted annually from the Development International Birth Date (DIBD). It serves as a tool to keep regulators, ethics committees, and investigators informed of the evolving safety profile of the investigational drug.

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