European clinical trials database EUDRACT

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

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

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. 

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)... 

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

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. 

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. 

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. 

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). 

---