US and EU regulators consider that the DSUR, submitted annually, would meet national and regional requirements currently met by the US Investigational New Drug Annual Report and the EU Annual Safety Report, respectively, and will therefore take the place of existing safety reports.
The main objective of a DSUR is to present a comprehensive 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:
For international trials, reference on DSUR production and submission will be detailed in contractual agreements and/or specific protocol documents.
It is the responsibility of the sponsor to send our DSUR reports annually for every ctIMP study to the MHRA and to the main REC.
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Research & Development
North Bristol NHS Trust
Level 3, Learning & Research building
Southmead Hospital
Westbury-on-Trym
Bristol, BS10 5NB
Telephone: 0117 4149330
Email: research@nbt.nhs.uk