DSURs must be submitted at yearly intervals from the date of the CTA approval. For trials with marketed products, the date is the first marketing authorisation granted in the EU.
The DSUR is a complex document written according to ICH E2F and includes the following:
Relevant Findings from Non-Interventional Studies
Relevant Findings from Other Studies
Safety findings from marketing experience
Overall Safety Assessment:
Consolidated safety reporting systems at PrimeVigilance, together with extensive in-house medical expertise provide the means for accurate and through DSUR production.
PrimeVigilance – Accurate and Thorough
+44 (0)1483 307920
(+1) 781 703 5540
United Kingdom (Head Office)