EudraCT Public Web Site will be unavailable from 12:00 noon (UK time) Friday 2 June 2006 until Monday 5 June 2006
EudraCT - Deployment of Lot 2A Version 3 into production.
EudraCT Version 3.0.1 will provide enhanced functionality to assist Sponsors and National Competent Authorities (NCAs).
In order to achieve this, it will be necessary to close access to the current EudraCT Version 2.04.01 Production Public and Secure Web Sites starting 12:00 (UK time) Friday 2 June 2006 until Monday 5 June 2006
Sponsors contemplating preparing or editing a Clinical Trial Application (CTA) in this period need to:
- Obtain EudraCT Numbers in advance of 12:00 noon on Friday 2 June 2006.
EudraCT Numbers, obtained now, will work in Version 3.0.1.
- Complete and save their Clinical Trial Application form NOW! before 12:00 noon on Friday 2 June 2006.
XML files, saved now, will work in Version 3.0.1 (some fields will require editing – See Frequently Asked Questions (FAQs)).
EudraCT Version 3.0.1 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 3.0.1 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 remains accessible only to the Competent Authorities of the Member States, the EMEA and the Commission.
(FAQs) Frequently Asked Questions have been published and are being revised in line with the Version number i.e. 3.0.1. only.
Additional documentation will also be published in the next week supporting the rollout of the new version.
There is a link to the EudraCT Web Site available from the EMEA home page http://www.emea.eu.int .