Registration in EudraCT database
Research with a medicinal products subject to the Dutch WMO Act must be registered in the EudraCT database. The EudraCT database was established to provide authorities more insight into interventional clinical trials on medicines conducted in the European Union (EU). The database is confidential and accessible only to the competent authorities of the different Member States. In addition, a public EU Clinical Trials Register exists in which the core data from European clinical trials are listed.
In the case of an amendment of the EudraCT Application form, you need to save the form as an XML file (using 'save as XML' and then 'download XML’) and PDF (via save 'pdf'). If submitting the form to the reviewing committee, you need to submit a signed copy. The pdf for the competent authority does not have to be signed. You must upload the XML file to the ToetsingOnline system (question B1a of the ABR form). It is therefore not necessary to submit the XML file together with the research file. The competent authority will enter the amended information in the EudraCT database.