The EudraCT Number station follows the Unique Trial Number station and precedes the Confirm Sponsor station. This process occurs in parallel with Funding Secured, Trial Master File, Feasibility & Investigator Selection, and Contract & Agreements. The EudraCT Number is a legal requirement for trials within the Clinical Trial Regulations scope. This station is part of the ‘trial planning phase’ group of stations.
All Clinical Trials of Investigational Medicinal Products (CTIMPs) that have sites in the EU must be registered on the EudraCT database. This database has been established to:
- support supervision of CTIMPs
- facilitate communication between competent authorities
- link with other databases such as EudraVigilance and the EU Clinical Trials Register.
Each trial must be issued with a unique EudraCT number.
Researchers should apply via the EudraCT website by clicking ‘Login to EudraCT’ and then ‘Create’ and ‘EudraCT number’ before completing the registration form. The unique EudraCT number generated 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 e-mail containing the EudraCT number should be printed and filed.
As the trial progresses, the EudraCT number will be the main identifier for that trial and should be included on all correspondence (for example when reporting substantial amendments and safety reports).
It is mandatory for clinical trial summary results to be posted in EudraCT within six to twelve months following the end of the trial (depending on the type of trial). It is the sponsor’s responsibility to ensure that this is done.
Non-CTIMP research does not require a EudraCT number.