Clinical Trial Application Menu Overview

The Clinical Trial Application Menu is the hub of the 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. system:

• A valid EudraCT NumberWhen registered, each trial is issued with a unique EudraCT number, which identifies the protocol and trial throughout its lifespan. entered through the Welcome Page of EudraCT.
• All users of EudraCT may access this functionality if the above prerequisites are met.

Interactive Image Map

Click on the various elements in the image below to jump to relevant sections of the Help. The same help is also available contextually on each page of the application through the button at the top of the page.

From this starting point, users can make a Clinical Trial Application within the EEAAcronym: European Economic Area. Created in 1994, the EEA combines the countries of the European Union and member countries of EFTA (European Trade Association) Countries that belong to the EEA are: Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom. Countries that are EEA member countries but NOT part of the European Union are: Norway, Iceland, and Liechtenstein., or in a Third CountryA third country is a country outside of the European Union/European Economic Area.. This completed, a package can be created, ready for submission to a National Competent Authority or to the EMAAcronym: European Medicines Agency.

In addition, registered users, such as PIPAcronym: Paediatric Investigation Plan. Document upon which the development and authorisation of medicinal products for the paediatric population is based. It is presented by an applicant early during the development of a product to the EMA Paediatric Committee in order to agree a paediatric development plan. addresses can log in to the system to perform tasks relating to their roles.

XMLAcronym: eXtensible Markup Language documents of the CTAAcronym: Clinical Trial Applications may be uploaded from a local area using the Clinical Trial Application button. "Load a Clinical Trial Application or Third Country CT Information".

To return to the Welcome page at any time, click in the Top bar:

• Note that the currently loaded CTA and any progress you may have made will not be saved automatically, should you choose to return to the Welcome Page.
• The Session Information indicates your login name and the organisation that login is associated with.
• The CTA Information panel on the left hand part of the screen indicates which CTA is currently loaded in the system.