Is my project a clinical trial?

If you are unsure, or want to verify your decision please check the algorithm from the MHRA, see below.

It is advisable to work through this document at an early stage in planning your study.

If you believe that it is a CTIMP, your study will need approval from the Medicines and Healthcare Products Regulation Agency (MHRA) in addition to the Research Ethics Committee (REC) opinion and NHS permission.

Detailed guidance from the MHRA can be found at the link below.

Another important aspect to consider is to identify an appropriate source for your medicine that you wish to use in your trial. The medicines under investigation in your trial, the so called “Investigational Medicinal Products” (IMPs), have very specific requirements. Therefore it is important to involve pharmacy early on.

The Department of Health and the Medical Research Council provide a clinical trials toolkit which provides information on all aspects of setting up and running a CTIMP.