Registration in EudraCT database
Research with medicinal products 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.
After you have applied for and received an EudraCT number, you can fill in the EudraCT application form (Clinical Trial Application Form) on the EudraCT website. Savethe completed EudraCT application form on to your own computer as an XML file (using 'save as XML' and then 'download XML’) and PDF (via save 'pdf').
It is wise to save the XML file onto your computer during the process of filling in the form, so that you can continue at a later time to complete it if necessary (upload XML file in EudraCT via ‘Load’). To check if the form is filled in correctly, you can validate it (via ‘validate’). The competent authority will check the form for validation errors.
A signed hard copy version of the EudraCT Application Form must be submitted to the reviewing MREC. The pdf is for the competent authority. This version 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 submit the XML file to the EudraCT database.