Research & Development Directorate

Carrying out Research > CTIMPs

Scope of Regulations

With effect from 1st May 2004 all clinical trials involving medicines must comply with the Medicines for Human Use (Clinical Trials) Regulations 2004. The regulations can be found at http://www.mhra.gov.uk

Main implications:

• All trials must identify a sponsor which takes responsibility for the initiation, management and/or financing of a clinical trial
• All trials must be authorised by the Licensing Authority (LA) prior to commencement
• No exemptions e.g. DDX, CTX
• Legal basis for implementation of the principles of GCP
• Standardisation of procedures and timelines for ethics and Competent Authority consideration and approval
• Requirement for approval of phase I clinical pharmacology studies on healthy volunteers
• Manufacture of IMPs (including placebos and active comparators) only at licensed manufacturing sites under GMP conditions. Manufacture or importation from outside EU will require prior authorisation by LA.
• Legal authority to inspect trial sites (including hospitals and universities) and sponsors against agreed principles of GCP and GMP

Is your study a CTIMP?

The MHRA has developed an algorithm to determine if your study requires a clinical trials authorisation (CTA) prior to commencing. If you are still uncertain, please contact R&D - we will then obtain written confirmation from the MHRA. It is important that you determine this prior to completing your ethics application.

How to get started

Your first step should be to contact R&D if you wish the Trust to sponsor your study. We will assist in your CTA application and liaise with our pharmacy clinical trials team, as well as develop a sponsorship agreement for studies across several sites. It is important that we review your protocol at this stage, as the MHRA will require detailed information about trial management and pharmacovigilance.

You will first of all need to register your study on the European Clinical Trials database and obtain a EudraCT number, then proceed to completing your CTA application - see the MHRA page on How to submit a CTA.

Another invaluable resource is the CT Toolkit which has been developed by the DH and MRC in order to help at all stages of a clinical trial.

During your study

We have developed some guidelines to help you with the day to day management of your study. If the Trust is sponsor for your study it is vital that you keep us updated with any changes to your study protocol.

At the end of your study

Your study protocol must define an end of study point, and you are obliged to declare the end of your study to the MHRA. You must keep us updated when this happens, or if your study is extended.

Resources