All Clinical Trials of Investigational Medicinal Products which fall under the Medicines for Human Use (Clinical Trials) Regulations 2004, must be registered on the EudraCT database. The database has been established to provide an overview of all clinical trials in the EU and improve communications between competent authorities (such as the MHRA).
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. 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 of your clinical trial.
When registered, each trial is issued with a unique EudraCT number which identifies the protocol and trial throughout its lifespan. The number must be quoted on ethics approval and clinical trials authorisation forms.
To apply for a EudraCT number, please 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:
- 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 States is it anticipated that the trial will be run?
- If not, which EU/EEA member states 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. When the EudraCT number is forwarded to you, you will also receive a template which shows you the type of information that will need to be collected in order to report the results. Reviewing this template and making a plan to record the needed information will help you to report results in the future. You must report results within one year of submitting the end of study notification (or within 6 months for paediatric trials).
For further information please see the SOP on adding study details to public databases.