EMEA - EudraCT

Here are some documents as background information:

The following link defines the legal framework for establishing EudraCT: http://ec.europa.eu/enterprise/pharmaceuticals/clinicaltrials/clinicaltrials_en.htm

EudraCT can be found here: https://eudract.emea.europa.eu/

The data dictionary, which is derived from the Clinical Trial Application form and is used for Version 8 of EudraCT can be found here: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/application-form2009.pdf

In version 8, we will be making part of the information contained in the EudraCT system available to the public in accordance with the following guidelines and lists of data fields.

Guideline for "Article 57" trials "Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004". (2008/C 168/02) http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2008_07/c_16820080703en00030004.pdf

Associated with this guideline is the list of data fields to be made public. "List of fields contained in the 'EudraCT' clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/C168/02 (February 2009)". http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_02_04_guideline.pdf

Guideline for paediatric trials: "Communication from the Commission - Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006". (2009/C 28/01) http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_c28_01/2009_c28_01_en.pdf

Associated with this guideline is the list of data fields to be made public. "List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 and its implementing guideline 2009/C28/01 (February 2009)". http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_02_04_guideline.pdf

We will also be collecting information on Paediatric clinical trials conducted in third countries (i.e. outside of the EU/European Economic Area(EEA)) that form part of a Paediatric Investigation Plan (PIP) (paediatric clinical trials with sites in the EU/EEA are already included)

The following are the Business Use Cases that are relevant to the Version 8 release of EudraCT:

http://wiki.hl7.org/images/b/bd/EudraCT_-_Business_Cases.zip