EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all clinical trials commencing in the European Union after 1 May 2004. The EudraCT database was established in line with the 'Medicines for Human Use (Clinical Trials) Regulations 2004'.
A EudraCT number is a unique identifying number allocated to your trial. It is mandatory for all studies starting in the European Community on or after the 1 May 2004 involving the use of an Investigational Medicinal Product (IMP) to have a EudraCT number and to be registered on this database.
A EudraCT number is required in order to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a Clinical Trial Authorisation (CTA) and to apply for Research Ethics Committee (REC) approval for your study.
Applications for a EudraCT are made through the website. When applying, the form asks for a 'Sponsors protocol number'; in the absence of any other identifying number we suggest you use your WAHT R&D reference number (if you do not know this please contact the Research & Development Dept). Once a EudraCT number has been gained the remainder of the application can be completed on IRAS.
This site contains all relevant information on how to apply for a EudraCT number and additional supporting documentation. In addition to completing the EudraCT application, applicants should also complete the application for a Clinital Trials Authorisation (CTA) and save it.