Welcome to EudraCT – the Community Clinical Trial system
EudraCT is a database of all clinical trials commencing in the Community from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC. The sponsor portal is available on the Internet, and gives access to the application in order to:
- get a EudraCT number – Available from 14 April 2004
- complete, save and print an electronic version of the clinical trial application form – Available from end April 2004.
The database itself is confidential and accessible only to the Competent Authorities of the Member States, the EMEA and the Commission.
EudraCT Number – Identification of the clinical trial
In order to provide a unique reference for clinical trials with at least one site in the Community, each trial will be given a unique number - the EudraCT Number, which must be included on all Clinical Trial applications within the Community and as needed on other documents related to the trials (e.g. SUSAR reports). Step 1 and 2 below access the forms that must be submitted in order to obtain a EudraCT Number.
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
EudraCT Number Step 1 – Apply for Security Code
The first step is to obtain an authenticated security code. This security code will be sent to the e-mail address specified by you, the requestor, on the form, and is needed in order to complete the EudraCT Number request. The security code is valid for one EudraCT Number only and expires after 24 hours.
EudraCT Number Step 2 – Apply for EudraCT Number
This is the main EudraCT Number request that allows the requestor to obtain a EudraCT Number. The EudraCT Number will be sent to the e-mail address specified by you, the requestor, on the form.
Sist gjennomgått: 02.08.2005
Første gang publisert: 16.04.2004