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Development Safety Update Report (DSUR)

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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.