European clinical trials database

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)... 

There can be no doubt that the principles that underlie European labeling are the same as those enumerated in other jurisdictions. Consistency of promotional materials with the approved package insert, the absence of misleading information in package inserts, fair balance, absence of relevant omissions and defensibility of all statements from the clinical trials database are also characteristic of good European labeling. 

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. 

Setting up of a European database for all member states with clinical trial information (to limit unnecessary trials)... 

Information on the content, commencement and termination of a clinical trial should be available to the Member States where the trial takes place and all the other Member States should have access to the same information. A European database bringing together this information should therefore be set up, with due regard for the rules of confidentiality. 

Member States in whose territory the clinical trial takes place shall enter in a European database, accessible only to the competent authorities of the Member States, the Agency and the Commission ... 

At the substantiated request of any Member State, the Agency or the Commission, the competent authority to which the request for authorisation was submitted shall supply aU further information concerning the clinical trial in question other than the data already in the European database. 

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. 

Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance—Clinical Trial Module). April 2003. ENTR 6101/02... 

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). 

---