EudraCT
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all clinical trials of investigational medicinal products with at least one site in the European Union commencing 1 May 2004 or later. The EudraCT database has been established in accordance with Directive 2001/20/EC. The EudraCT Number is unique and is needed on other documents relating to the trials (e.g. SUSAR reports).
The public side of EudraCT is for organisations to register any of their clinical trials as defined by Directive 2001/20/EC. The process of applying and registering a clinical trial should be completed before submitting an application to any of the Member State/s in which they anticipate running the trial. The public side of EudraCT does not save any of the trial detail entered by the user, and instead provides a saved data file in the form of an XML which the user must store on their own local hard drive.
Application for an EudraCT number is made via the EudraCT website. To generate the EudraCT number some basic information about the requestor's organisation and the trial is required:
Once the requestor submits the form, the EudraCT Number will be assigned and an e-mail called "EudraCT Receipt" sent. The EudraCT number has the format YYYY-NNNNNN-CC, where:
The Clinical Trial Application (CTA) form is also created via the EudraCT system.
The EudraCT database is currently on Version 9.
Version 9 of EudraCT was released in November 2013.
New features for Version 9 include:
Protocol-related information
Sponsors can:
PIP addressees can:
Result-related information
Results users can:
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