EudraCT

The public side of EudraCT is for organisations to register any of their clinical trials as defined by Directive 2001/20/EC. The process of applying and registering a clinical trial should be completed before submitting an application to any of the 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.

Application for a EudraCT number is made via the EudraCT website. To generate the EudraCT number some basic information about the requestor's organisation and the trial is required:

• Requestor's organisation name, town/city and country.
• Sponsor's protocol number.
• Requestor name.
• E-mail to which the EudraCT number will be sent.
• Security code.
• Whether the clinical trial is contained in a Paediatric Investigation Plan (PIP).
• Whether the clinical trial will be conducted in a third country (outside of the EU/EEA).
• The Member States where it is anticipated that the trial will be run.

Once the requestor submits the form, the EudraCT Number will be assigned and an e-mail called "EudraCT Receipt" sent. The EudraCT number 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.

The Clinical Trial Application (CTA) form is also created via the EudraCT system.

The EudraCT database is currently on Version 9.

Version 9 of EudraCT was released in November 2013.

New features for Version 9 include:

Protocol-related information

Sponsors can:

• Create, save XML/PDF files of clinical trial applications locally.
• Load locally saved clinical trial applications to complete, validate, compare, or to prepare a package for submission to a National Competent Authority.

PIP addressees can:

• Create, save XML/PDF files of third country files locally.
• Create and post third country files to the EudraCT database.
• Load locally saved third country files to complete, validate or post to the EudraCT database. To post third country files you will need to be registered as a PIP addressee.

Result-related information

• To use result related functionality you will need to be registered as a results user, and log in.

Results users can:

• Create, update, validate and post result data sets, and load summary attachments to the EudraCT database.
• Save locally XML/PDF files of result data sets.
• Upload XML files.

Source

• European Medicines Agency
• EUDRANET
• EudraGMP
• EudraPharm
• EudraVigilance

• EudraCT
• EudraCT Supporting Documentation
• EudraCT FAQ
• International Standard Randomised Controlled Trial Number Register (ISRCTN)
• EU Clinical Trials Register (EU-CTR)