Development Safety Update Report

The Development Safety Update Report is an annual review of safety information during clinical trials of a medicine under investigation “ whether or not it is marketed. The main objectives of a Development Safety Update Report is to:

  • Summarise the current understanding and management of identified and potential risks.
  • Describe new safety issues that could have an impact on the protection of clinical trial participants.
  • Examine whether any new safety information is in line with previous knowledge of the product™s safety.
  • Provide an update on the status of the clinical investigation/development programme and study results.

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