EudraCT System UNAVAILABLE for clinical trial applications

The EudraCT system will be unavailable from 14th-18th November inclusive. This will affect you if you are preparing a CTA in this period.

The EudraCT web site will be unavailable from 14 - 18 November 2005 inclusive to allow upgrades to the system.

This will affect you if you are preparing or editing a Clinical Trial Application (CTA) in this period.

It is important that you:

• Obtain EudraCT Numbers NOW, before 12:00 midnight on Sunday 13 November 2005. EudraCT Numbers, obtained now, will work in the new version.
• Complete and save your CTA form NOW, before 12:00 midnight on Sunday 13 November 2005. XML files, saved now, will work in Version 3.0.0 (although some fields will require editing – an FAQ will be published on the EMEA wesbite http://www.emea.eu.int)

The new EudraCT Version 3.0.0 will include:

• Changes to the Clinical Trial Application (CTA) form
• 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.
• New functionality for Compenten Authorities (e.g. MHRA) including alerts when trials are refused, interrupted or terminated early