EudraCT database

Detailed guidance on the European clinical trial database (EuDRACT database) ENTR/F2/BL D (2003). 

EMEA web site www.emea.eu.int EuDRACT database homepage http //eudract.emea. eu.int... 

European Commission. Detailed guidance on the European clinical trials database (EuDRACT Database). April 2003, and successor documents CT 5.1 Amendment describing the development of EUDRACT-Lot 1 (May 1, 2004) and CT 5.2 EUDRACT core dataset. 

E. Exchange of Information, Suspension or Infringements, European Clinical Trials EUDRACT Database... 

The CA in whose territory the CT takes place enters the details into a new European Drug Regulatory Affairs Clinical Trial (EUDRACT) database. It allocates a unique EUDRACT number that cannot be reallocated to another trial if the original one does not proceed if an International Standard Randomized Controlled Trial Number (ISRCTN) is available, this detail is also entered. These EUDRACT entry data are accessible only to the CA, the EMEA, and the Commission and details the request for authorization, the protocol, any proposed protocol amendments, approvals by the CA and IEC, any suspension, the declaration at the end, and reference to any GCP inspections. 

EU draft guidelines 1705-1707 EUDRACT database 1697 EUDRALex 1670, 1677, 1682 EUDRANet 1677 EUDRATrack 1677 EudraVigilance 1677 EU guidelines... 

As a consequence of the new legislation for clinical trials, documentation on the quality and preclinical (i.e., toxicological) data of investigational medicinal products, including radiopharmaceuticals, needs to be submitted to obtain approval from the national health authorities in the member states prior to initiating a clinical study in humans. Furthermore, all clinical trials which started in the European Union after 1 May 2004 need to be recorded in the European EudraCT database (European Commission 2003 b). 

The year 2003 saw the launch of the European Clinical Trials (EudraCT) Database (https //eudract.emea.eu.int/eudract/index.do). The database is interfaced with the Eudravigilance Clinical Trial Module (EVCTM), and is used to facilitate communication on clinical trials between authorities in the oversight of clinical trials and investigational medicinal product development, and to provide for enhanced protection of clinical trial participants receiving investigational medicinal products. 

The next step is to identify the sponsor as defined in the Research Governance Framework (Department of Health, 2005) and SI 2004 1031. The identity of the sponsor is required for both the ethics application and EudraCT database. All drug trials should register with the EudraCT database. Where the trial has co-sponsors, these should be identified. The MHRA algorithm (MHRA, 2006) will enable researchers to decide whether the trial is under UK regulation. 

The application for a clinical trial authorisation (CTA) for the first administration of a NME to man comprises the same elements as all other CTAs but, of course, there will be no clinical data. The regulatory authority known as the competent authority (CA) of the EU member state requires receipt of confirmation of the EU clinical trials database (EUDRACT) number, a covering letter, a completed application form, the protocol with all current amendments, the IB and a full Investigational Medicinal Product Dossier (IMPD) (see below). If the study is to be conducted in more than one member state, a list of CAs should be included. If the opinion of the lEC is available, it should be provided. 

European Clinical Trials Database. EudraCT supporting documentation, http // eudract.emea.eu.int/document.html... 

Directive 2001/20 had a major impact on phar-macovigilance in Europe because it demanded the creation of a pan-European safety database for all medicinal products in the market and extending to IMPs. The system was named EudraVigilance. The EuDRACT system (clinical trials registration, see above) was created as part of it. The detailed guidance about reporting of adverse reactions to IMPs, whether licensed or not, was issued in April 2004. 

European Commission (2003 b) Detailed guidance on the European clinical trials database (Eu-draCT Database). http //pharmacos.eudra.org/F2/pharmacos/docs/Doc2003/april/cp-guidance-eudract 230403.pdf)... 

---