How to obtanin EudraCT number

 

EudraCT is a clinical trials database that includes the registration of clinical trials. The process for obtaining approval from the Ethics Committee (CEIm) and authorization from AEMyPS (the Spanish Agency of Medicines and Medical Devices) started on May 1, 2004. This database complies with Directive 2001/20/EC.

The sponsor can access the following features through the application to:

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

The database is confidential and can only be accessed by 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 on 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 following Steps 1 and 2 explain the process 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 six-digit sequencial number.
• CC is a control number to automatically verify 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 required to subsequently perform the EudraCT number request. 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 actually the request for the EudraCT number which will allow the applicant to obtain that 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