EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all clinical trials commencing in the European Community from 1 May 2004 onwards. The European Union ( EU) is a political and economic union of twenty-seven member states, located primarily in The EudraCT database has been established in accordance with Directive 2001/20/EC. Directive 2001/20/EC or Clinical Trials Directive of 4 April 2001 of the European Parliament and of the Council on the approximation of the laws Regulations and administrative
Each clinical trial with at least one site in the European Community, receives a unique number for identification, the EudraCT Number. The EudraCT Number must be included on all Clinical Trial applications within the European Community and as needed on other documents relating to the trials (e. g. SUSAR reports).
The unique EudraCT number for each clinical trial has the format YYYY-NNNNNN-CC, where:
- YYYY is the year in which the number is issued.
- NNNNNN is a six digit sequential number.
- CC is a check digit.
The first step to apply for the EudraCT Number is to apply for a Security Code. In the second step the requestor can apply for theEudraCT Number itself.
See also
References
External links
- EudraCT
- EudraCT Supporting Documentation
- EudraCT FAQ
- International Standard Randomised Controlled Trial Number Register (ISRCTN)