Definition

An annual safety report for investigational drugs submitted during clinical development to regulatory authorities and ethics committees.

Example

The DSUR summarizes all clinical trial safety data from the past year, analyzes emerging safety findings, and updates the benefit-risk assessment for continued development.

Regulatory source

ICH E2F

Common mistakes

Not including relevant safety data from all ongoing trials globally, or providing inadequate analysis of aggregate safety findings.

Inspector question

Show me your DSUR preparation timeline. How do you ensure all global trial data is captured?

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