This is an annual safety report that must be submitted to the MHRA for Clinical Trials of Investigational Medicinal Products (CTIMPs).
The purpose of a DSUR is to present a comprehensive, scientific annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed, by:
- Examining whether the information obtained by the sponsor during the reporting period is in accord with previous knowledge of the product’s safety.
- Describing new safety issues that could have an impact on the protection of clinical study participants.
- Summarising the current understanding and management of identified and potential risks.
- Providing an update on the status of the clinical investigation / development programme and study results.