EudraCT is a clinical trials database that should include clinical trials in which both the process of obtaining the CEIm opinion and the authorization by AEMyPS begins as of 1 May 2004. This database complies with Directive 2001/20/EC.
The sponsor can access the application via the Internet in order to:
Obtain the EudraCT number – Available since 15 April 2004 http://eudract.emea.europa.eu
Complete, save and print an electronic version of the application form – Available since the end of April 2004.
The database is confidential and will only be accessible to the Competent Authorities of the Member States, the EMEA and the Commission.
EudraCT Number – Clinical Trial Identification:
To provide a unique reference number for clinical trials conducted in at least one country of the European Economic Area, each trial must be identified by a unique number, – EudraCT number -, which must appear in all clinical trial applications submitted in a Member State and will be used as an element to identify the trial in the corresponding documentation (e.g. in notifications of serious and unexpected adverse reactions. The EudraCT number will be assigned centrally and steps 1 and 2 below indicate how to proceed to obtain it.)
The EudraCT number has the format AAAA-NNNNNN-CC, where:
YYYY is the year in which the number is issued.
NNNNNN is a six-digit sequential number.
CC is a control number that allows you to automatically check that the number has been written correctly.
Step 1 to obtain the EudraCT number – Request for a Security Code
The first step is to obtain a security code – This will be sent to the email address specified by the applicant (promoter or person authorized by him in the application) and is necessary to be able to subsequently make the EudraCT number request. The security code will be valid for a single EudraCT number and will expire in 24 hours.
Step 2 to obtain the EudraCT number – Request for the EudraCT number
This is actually the request for the EudraCT number that will allow the applicant to obtain said number. The EudraCT number will be sent to the email address specified by the applicant in the application.
To obtain the EudraCT number, connect to: http://eudract.emea.europa.eu
