EudraCT - AbsoluteAstronomy.com

EudraCT is the European Clinical Trials Database

Clinical trials registry

A clinical trials registry, sometimes abbreviated as a CTR, is an official platform and catalog for registering a clinical trial. Some countries require clinical trials being conducted in that country to be registered, other do not require it, but often strongly encourage it...

of all clinical trial

Clinical trial

Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...

s commencing in the European Union

European Union

The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...

from 1 May 2004 onwards. The EudraCT database has been established in accordance with Directive 2001/20/EC

Directive 2001/20/EC

The Clinical Trials Directive is a European Union directive that aimed at...

.

Each clinical trial with at least one site in the European Union receives a unique number for identification, the EudraCT Number. The EudraCT Number must be included on all Clinical Trial applications within the European Community and as needed on other documents relating to the trials (e.g. SUSAR reports).

Public Side

The Public Side of EudraCT is for organisations to register any of their studies which under the Directive 2001/20/EC

Directive 2001/20/EC

The Clinical Trials Directive is a European Union directive that aimed at...

are considered a Clinical Trial. The process of applying and registering a Clinical Trial should be completed before submitting an application to any of the Member States. The Public Side of EudraCT is also where the user enters all the details of the trial on the Clinical Trial Application form required to support their application to each individual Member State/s in which they anticipate running the trial. The Public Side of EudraCT does not save any of the trial detail entered by the user, and instead provides a saved data file in the form of an XML which the user must store on their own local hard drive.

Applying for a EudraCT Number

You can only apply for a EudraCT number via the EudraCT website. To generate the EudraCT number some basic information about the requestor's organisation the trial is required. To access this section you will need to click on the create button, then select EudraCT Number, from the drop down list. You will then be presented with the following fields:

Requestor's organisation name

Requestor's organisation town/city

Requestor's organisation country

Sponsor's protocol code number

Requestor name

Requestor last name

E-mail to which the EudraCT number will be sent

Security code

Is it anticipated that this EudraCT Number will be used for a Clinical Trial contained in a Paediatric Investigation Plan (PIP)?

Is it anticipated that this EudraCT Number will be used for a Clinical Trial conducted in a third country (outside of the EU/EEA)?

Please select the Member States where it is anticipated that the trial will be run

Once the requestor submits the form by clicking on 'Get EudraCT Number' they will be taken to a new page which shows the uniqie EudraCT number for this trial. An e-mail called "EudraCT Receipt" will also be issued containing their EudraCT number for this trial. The unique EudraCT number for each clinical trial has the format YYYY-NNNNNN-CC, where:

YYYY is the year in which the number is issued.

NNNNNN is a six digit sequential number.

CC is a check digit.

Creating your Clinical Trial Application

The Clinical Trial Application (CTA) form is created via the EudraCT system. If you are about to create your form for the first time that you will have to select the 'Create' button, then 'Clinical Trial' then 'EEA'.

You will then be presented with a screen to select the country the application is for, along with the EudraCT number. A blank application will then be generated, which you can complete within the EudraCT system.

If you have previously created a saved an application within EudraCT, then you should click on 'Load' and upload the corresponding XML data file for the submission you wish to update/amend.

For help creating/amending your application within EudraCT, please refer to the help documentation ..

Version details

The EudraCT database is currently on Version 8.1.1.

Version 8 was released in March 2011 and involved a major change to the EudraCT system, and how the data is stored. These changes were made in preparation for the launch of the Clinical Trials Register which is a public database that displays information from within EudraCT.
New features in version 8 are: https://eudract.ema.europa.eu/version8info.html