Is my study a Clinical Trial of an Investigational Medicinal Product (CTIMP)?
A Clinical Trial of an Investigational Medicinal Product (CTIMP) is a clinical trial or study that is evaluating the safety or efficacy of a drug (Investigational Medicinal Product) or obtaining any other information about the drug e.g. how it is absorbed, distributed, metabolised or excreted.
If the trial is being conducted for a reason other than ascertaining the effects of, or reactions to, a product it is simply being used as an aid or tool in the study and is not a CTIMP.
Example one - a CTIMP
A trial assessing whether paracetamol relieves headaches is a CTIMP and paracetamol is the Investigational Medicinal Product (IMP).
Example two - not a CTIMP
For example, a study of blood flow includes the infusion of a vasoactive drug to monitor or establish the effects of this vasoactive drug to see if it is effective in achieving a particular physiological effect. This is not a CTIMP.
The Medicines and Healthcare Products Regulatory Agency’s (MHRA) algorithm can help you work out if your study is a CTIMP.