What is the procedure?
You should send a Development Safety Update Report once a year. Safety reports are submitted from the date of submission of the investigation file to the end of the investigation in the Netherlands. The end of the study is usually the last visit of the last patient, unless otherwise specified in the study protocol. For more information, consult the CCMO website.
What should I submit?
What should I pay attention to?
If there are no reports in the relevant period, please send a document stating this.
The DSUR may be presented together with the annual progress report (APR).
Please pay attention to the following parts of the safety report:
- An overall conclusion
- A conclusion in terms of the benefit/risk-ratio