EudraCT unavailable from 14 to 18 November 2005

EudraCT Version 3.0.0 will provide enhanced functionality to assist Sponsors and National Competent Authorities (NCAs).

Important Information - Sponsors 

Sponsors contemplating preparing or editing a Clinical Trial Application (CTA) in this period need to get a EudraCT number and/or save Application Form in the EudraCT database within midnight sunday 13. november or await until after 18. november.

EudraCT Numbers, obtained now, will work in Version 3.0.0. and xml files, saved now, will work in Version 3.0.0 (some fields will require editing – See Frequently Asked Questions (FAQs) to be published shortly).

Evaluation of Applications

EudraCT Public Web Site will be unavailable for both sponsors and NCAs during this period, and NoMA will therefor not be able to evaluate trials in this timeframe.

EudraCT Version 3.0.0 will include:

• Changes to the Clinical Trial Application (CTA) form as agreed by the NCAs and published by the European Commission -http://dg3.eudra.org/F2/pharmacos/docs/Doc2005/10_05/CA_14-2005.pdf
  
• A look up list of authorised active substance names (INN, etc) to enable completion of the CTA form and XML file with consistent coded information accessible from the EudraCT Public Web Site.
  
• A look up list of MedDRA terms and codes to enable completion of the CTA form and XML file with consistent coded information on the therapeutic indication, accessible from the EudraCT Public Web Site.
  
• In addition, Version 3.0.0 will provide important new functionality for NCAs including alerts when trials are refused, interrupted or terminated early, as well as the benefits of using coded data for active substance names and therapeutic indication (MedDRA).

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

• Frequently Asked Questions will be published shortly (FAQs).
• There is a link to the EudraCT Web Site available from the EMEA home page http://www.emea.eu.int.