EU Clinical trials

If you are planning a research project involving administering medicinal products to people, your study may fall under the EU Clinical Trials Directive and will therefore need to meet more regulatory criteria than other kinds of research projects.

We have set up a special unit headed by Julie Uttridge to help you deal with the extra issues involved.

Is my project a clinical trial?

This is not quite as clear-cut as it might sound. First download the Clinical Trial Algorithm. It is advisable to work through this document at an early stage in your study and to call the MHRA Helpline (number given on the algorithm) or contact for advice if you are in any doubt. This will help you define whether any substances you are planning to administer count as medicines.

Clinical Trial Algorithm (26 KB)

If they do, your study will need approval from the Medicines and Healthcare Products Regulation Agency (MHRA) in addition to the normal peer review, ethical, and sponsorship approvals. You can read the detailed guidance of the MHRA here:

> MHRA

The Department of health and the Medical Research Council also provide detailed guidance here:

> Clinical Trials Tool Kit

How do I set up a clinical trial?

For work done with patients and volunteers on the Addenbrooke's site, the R&D department can help you with all the necessary approvals. Before work starts we must be satisfied that proper arrangements have been put in place for:

Our Index of Essential Documents is a quick guide to the bases you will need to cover and includes:

• Protocol (a clinical-trial specific template is available)

 

• Peer review

 

• Ethical approval

 

• Clinical Trials Authorisation from the MHRA pharmacy and the control of medicines

 

• The pharmaceutical company's Investigators Brochure for the drug or SmPC

 

• Radiation protection

 

• Sponsorship and liability cover

 

• Tissue supply issues

 

• Contracts

 

• Safety reporting and monitoring

 

• Honorary contracts

Contact Julie Uttridge for guidance on any of these matters. These processes all take time and proper advance planning can save you time, trouble and money in the long run.

Will Addenbrooke's sponsor my trial?

Clinical trials conducted by local researchers may be sponsored by Addenbrooke's or by the hospital in partnership with the University of Cambridge. Alternatively, trials may be sponsored by other hospitals and academic institutions, of which our site is just one of many taking part. In the latter case, we still need to ensure that all approvals are in place by the remote sponsor before work can go ahead.

Managing a clinical trial

Proper management of clinical trials in the Trust is covered by overall policies and procedures contained in the documents below, which detail the overall management processes, the proper way to get consent from patients for their involvement and how to report any adverse incidents which may occur during the trial.

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