A CTIMP is defined as any investigation in human subjects intended to:
- discover or verify the clinical, pharmacological and/or pharmacodynamic effects of one or more IMP(s)
- ascertain the safety of one or more IMP(s)
- study absorption, distribution, metabolism and excretion of one or more IMP(s)
The Medicines and Healthcare products Regulatory Agency (MHRA) has developed an algorithm (PDF) to help you determine whether or not the proposed clinical research is within the scope of the Clinical Trials Regulations. If you remain unsure, please contact CTRG.