Development Safety Update Reports

The purpose of this SOP is to describe the process for preparing and submitting DSURs for clinical trials to Regulatory Competent Authorities and RECs for clinical trials sponsored or co-sponsored by King’s Health Partner Organisations.

The DSUR is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. US and EU regulators consider that the DSUR, submitted annually, would meet national and regional requirements currently met by the US IND Annual Report and the EU Annual Safety Report, respectively, and will therefore take the place of these existing reports.

The main objective of a DSUR is to present a comprehensive, thoughtful 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:

  1. examining whether the information obtained by the sponsor during the reporting period is in accord with previous knowledge of the investigational drug’s safety;
  2. describing new safety issues that could have an impact on the protection of clinical trial subjects;
  3. summarising the current understanding and management of identified and potential risks;* and
  4. providing an update on the status of the clinical investigation/development programme and study results.
SOP: Development Safety Update Reports (6500Kb) 

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