Development Safety Update Reports
Guidance on preparing and submitting Development Safety Update Reports (DSURs).
Development Safety Update Reports (DSURs)
Development Safety Update Reports (DSUR) are internationally recognised annual safety report that sponsors must submit to regulatory authorities and research ethics committees.
A single DSUR is normally prepared per Investigational Medicinal Product (IMP) and covering all associated trials. It applies to all IMPs in development, including marketed drugs under further study.
The trial sponsor is responsible for the preparation, content, and submission of each DSUR. The KHP-CTO Quality Manager (or delegate), together with the relevant Chief Investigator(s), will determine the most appropriate preparation route for each trial and drug.
This SOP describes the procedures for preparing and submitting Development Safety Update Reports (DSURs). It applies to all clinical trials sponsored, co-sponsored, or managed by KHP organisations and conducted in the United Kingdom.