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.