EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all CTIMPs with at least one site in the European Union (predominantly for CTIMPS started prior to January 1, 2021).
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 REC approval of your clinical trial. CTIMPS which began before 2021 will still need to register and report results on EudraCT. CTIMPS beginning on or after January 1, 2021, will only need to apply for a EudraCT number, but not report results on EudraCT.
Getting a EudraCT Number
Application for EudraCT Number: Send an email to the Research Integrity Officer providing the information requested below:
- Requestor's organisation name: Imperial College or Imperial College Healthcare NHS Trust
- Contact information (e.g. name and email address):
- Sponsor's protocol code number:
- Is it anticipated that this EudraCT Number will be used for a clinical trial contained in a Paediatric Investigation Plan (PIP)?
- Is it anticipated that this EudraCT Number will be used for a clinical trial conducted in a third country (outside of the EU/EEA)? If so, which member state is it anticipated that the trial will be run? If not, which EU/EEA member state do you expect the trial to run in?
You should receive a response within three working days. Once the EudraCT number has been created, it will be forwarded to you.
Clinical Trials Before January 1, 2021
For CTIMPS registered on EudraCT which began before 2021, you will still need to report results on EudraCT. After January 1, 2021, the MHRA will no longer have the ability to update information on EudraCT so you will need to email the MHRA when you have reported results on EudraCT by following the steps below:
- You must send a short confirmatory email to CT.Submission@mhra.gov.uk. The subject line of the email notification must state ‘End of trial : result-related information: EudraCT XXXX-XXXXXX-XX’ once the result-related information has been uploaded to the public register and provide a link. If your clinical trial is not on a public register, summary results should be submitted by email to CT.Submission@mhra.gov.uk. An acknowledgement letter will not be sent for this submission.
- You should also submit a final report to the Research Ethics Committee within the same timeframe for reporting the summary of results.
For further information please see SOP 022 on adding study details to public databases.