What is the procedure?
You should send a semi-annual safety update report once every six months. This should provide an overview of all SAEs / SUSARs for the study drug that have occurred since the last update of the IB or SmPC.
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.
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.
Please pay attention to the following parts of the safety report:
- An overall conclusion
- A conclusion in terms of the benefit/risk-ratio