To create a clinical trial application, you must first apply for a EudraCTEudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all interventional clinical trials of medicinal products commencing in the European Union from 1 May 2004 onwards. The EudraCT database has been established in accordance with Directive 2001/20/EC. number.
Please note: In the event a clinical trial application and a third country file should be prepared for the same clinical trial, the same EudraCT number must be used.
From the login page, select Create> EudraCT NumberWhen registered, each trial is issued with a unique EudraCT number, which identifies the protocol and trial throughout its lifespan. and the following page is displayed:
Note:Fields with an asterisk * are mandatory and must be input.
The EudraCT system will check that the sponsor’s protocol code number submitted on the form is unique within the EudraCT database. It is unlikely that different sponsors will use the same protocol code numbers for their trials. However, it may be that the submitted sponsor’s protocol code number already exists, in which case a warning message is displayed.
If different sponsors do use the same protocol code numbers for their trials, then within the community it is the EudraCT number that provides the unique reference to the sponsor’s trial. If the system detects a duplicate sponsor protocol code number, the system warns the requestor and in this case the most likely explanation is that a EudraCT number has already been requested by someone from the same organisation or another collaborator in the trial. The option is given to exit the system without creating a new EudraCT number so that checks within the organisation or trial collaborators can be completed.