Reporting of suspected unexpected serious adverse reactions (SUSARs)

In accordance with Article 31 of the Rules on clinical trials of medicinal products, the sponsor must regularly and in due time make known all suspected unexpected serious adverse reactions by sending the relevant data in electronic form directly to the European database “EudraVigilance-CT module.  

  • annual/periodic reports

The sponsor sends regular periodic and annual safety reports (DSURs) in accordance with Articles 32 and 33 of the Rules on clinical trials of medical products.

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