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How to obtanin EudraCT number

 

EudraCT is a database of clinical trials where clinical trials should be included which the process of obtaining the opinion of the CEIm as well as the authorization by AEMyPS begins as of 1 May 2004. This database complies with Directive 2001/20/EC.

The developer can access the Internet through the application in order to:

  • Obtain the EudraCT number - Available from April 15, 2004  htp://eudract.emea.europa.eu
  • Fill out, save and print an electronic version of the application form - Available from the end of April 2004.

The database is confidential and will only be accessible to the Competent Authorities of Member States, the EMEA and the Commission.

EduraCT number - Identification of the clinical trial

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 be recorded in all applications for The clinical trial presented in a Member State. It will be used as an element to identify the trial in the corresponding documentation (e.g. in the notifications of serious and unexpected adverse reactions. The EudraCT number will be allocated centrally and the Steps 1 and 2 that follow indicate how to proceed to obtain it.)

The EudraCT number is in the format AAAA-NNNNNN-CC, where:

  • AAAA is the year in which the number is issued.
  • NNNNNN is a sequential six-digit number.
  • CC is a control number that allows you to verify automatically that the number has been written correctly.

Step 1 to obtain EudraCT number - request a Security code
The first step is to obtain a security code. This will be sent to the email address specified by the applicant (sponsor or person authorized by him in the application) and it is necessary to be able to make the request later EudraCT number. The security code will be valid for a single EudraCT number and it will expire in 24 hours.

Step 2 to obtain EudraCT number - Application for the EudraCT number
This is really the request of the EudraCT number that will allow the applicant to obtain this number. The EudraCT number will be sent to the email address specified by the applicant in the application.

To obtain the EudraCT number link to: http://eudract.emea.europa.eu