On the 1 May 2004 the Medicines for Human Use (Clinical Trials) Regulations 2004 became UK law. Under these regulations there is now a legal requirement for researchers planning a trial to apply to the Medicines and Healthcare Products Regulatory Agency (MHRA) for a Clinical Trials Authorisation (CTA) before the trial starts.
The Regulations apply to clinical trials where there is a medicine in any of the treatment or control arms of the study, including trials with healthy volunteers. In addition, trials attempting to generate information on efficacy and/or safety of a medicine, including a standard treatment will also fall under the Regulations. Trials of interventions such as surgery where patients will be receiving medicines as part of standard treatment do not come under the Regulations. The MHRA has produced a 'clinical trial algorithm' to help you decide if you need to complete a CTA, please click below to view it.
If your trial is being funded and sponsored by a commercial company, you will not need to apply for CTA as this will be carried out on your behalf by the sponsor. For trials that are sponsored by Barts and The London NHS Trust (BLT) or Queen Mary University of London (QMUL), the sponsor will delegate the responsibility for completing the CTA to the Chief Investigator, but if you are unsure, please contact the Joint Research Office.
Obtaining a EudraCT number
If your trial falls within the scope of the Regulations you are required to register your project on the EudraCT database (developed by the European Medicines Agency - EMEA) by obtaining a EudraCT number. This number becomes the main identifier for the trial and should be used on all correspondence with the MHRA, ethics committee and when reporting protocol amendments or serious adverse events.
To obtain this number you should go to the EMEA website, www.emea.eu.int, and click on the EudraCT section. You will then need to apply for a security code, which will be sent to you via e-mail. On receiving the code you can apply for the EudraCT number on the same website and the number will be e-mailed to you immediately. This number should be added to your CTA form.
Apply for a Clinical Trials Authorisation (CTA)
If you are planning a trial using a medicinal product in humans, you must seek authorisation from the MHRA. The procedures for applying for a Clinical Trials Authorisation (CTA) changed with the implementation of the Clinical Trials Regulations. The MHRA now need more detailed information about the clinical trial and a fee is charged. However, the MHRA should give you a decision on your CTA form within 60 days and currently most decisions/approvals are being granted within 30 days of receipt.
Obtaining an ISRCTN (International Standard Randomised Controlled Trial Number)
It is advised that you should register your trial with an ISRCTN as some journals require evidence of this number prior to publishing a paper. Obtaining this number means that your trial is registered on an international database of randomised control trials. For more information, please visit www.controlled-trials.com.
After the start of your trial
For information about submitting trial amendments to the MHRA, adverse event reporting and trial closure please go to the ‘Managing your research project’ section.
For information on submitting annual safety reports please go to the 'Annual progress reports' section.
Please notify the Joint R&D Office when you have recruited your first patient.
More information
For more information about the Clinical Trial Regulations, please see the Clinical Trials toolkit which outlines a flowchart of procedures for setting-up, running and closing down clinical trials. To view the toolkit, please see www.ct-toolkit.ac.uk.
R&D Office submission
Clinical trials