Add Initial Required Information - EudraCT Number and National Competent Authority details

Task topic including all steps necessary for adding 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. number and the National Competent Authority (in the case of a planned 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. Clinical Trial) to the system.

Prerequisites for creating a CTAAcronym: Clinical Trial Application

To create a Clinical Trial Application or add Third CountryA third country is a country outside of the European Union/European Economic Area. Clinical Trial Information, the following prerequisites apply:

EudraCT number.
Name of the National Competent Authority concerned with the Clinical Trial Application.
Access to the EudraCT PUBLIC or SECURE application via the EudraCT home page:
https://eudract.ema.europa.eu/ / http://eudract.eudra.org/

For those in possession of a EudraCT NumberWhen registered, each trial is issued with a unique EudraCT number, which identifies the protocol and trial throughout its lifespan. and data ready for creating a Clinical Trial Application draft, or Third Country Clinical Trial Information, follow these steps:

In the Welcome page clickand select 'Clinical Trial' and then 'EEA' or 'Third Country' dependent on whether the EudraCT Number you are using is associated with an EEA Clinical Trial Application or a Third Country Clinical Trial Information.
In the Initial Required Information screen, click the drop-down field arrow and press the first letter of the National Competent Authority concerned by the Clinical Trial until the desired NCAAcronym: National Competent Authority is highlighted. Press Enter to select.
Insert the EudraCT Number for the Clinical Trial Application in the free text field (it may be cut and pasted). Note that each Clinical Trial is linked to a particular EudraCT number and may be used for one CTA only.
Note: If you do not have a EudraCT Number, clickand select from the top menu bar . See Create a EudraCT Number section for more details.
Finally, click and the Clinical Trial Application Menu appears with the CTA Information for the draft CTA and the associated NCA displayed clearly on the left-hand side of the screen.

See "Clinical Trial Application Menu Overview" for more detailed information on the process of creating a CTA.