Is my study a Clinical Trial of an Investigational Medicinal Product?
Most clinical research studies are required to adhere to the Research Governance Framework for Health and Social Care
Clinical Trials of Investigational Medicinal Products (CTIMPs) must also adhere to the European Clinical Trials Directive (2001/20/EC) , the Medicines for Human Use (Clinical Trials) Regulations 2004 and the Good Clinical Practice Directive (2005/28/EC)
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 investigational medicinal product(s) (IMP)
- identify any adverse reactions to one or more IMPs
- study absorption, distribution, metabolism and excretion of one or more IMPs with the object of ascertaining the safety or efficacy of those products.
The Medicines and Healthcare products Regulatory Agency (MHRA) has developed an algorithm to help investigators determine whether or not their proposed clinical research is within the scope of the Clinical Trials Regulations.
A definition of an investigational medicinal product and a non-investigational product is available here.
However, researchers should always seek advice and confirmation from the Medicines and Healthcare Products Regulatory Agency’s Clinical Trials Helpline, email@example.com and seek a written statement confirming whether the project falls under the Regulations. All correspondence sent to and received from MHRA should be retained in the Trial Master File.
When do the Regulations apply?
The Regulations will apply where:
- The trial will be conducted in one or more Member states of the European Union, Iceland, Norway or Liechtenstein. It may also include sites in non-EU countries
- The trial's purpose is to ascertain the safety and efficacy of one or more medicinal products in human subjects. This includes clinical effect, pharmacodynamics, adverse reactions and pharmacokinetics. A medicinal product is a medicinal substance used for treatment, prevention of diagnosis or disease.
The EU Directives and the UK Clinical Trial Regulations cover only investigations/studies which are undertaken to ascertain the efficacy or safety of a medicine in human subjects and which follow an ethically and regulatory approved research protocol.
Both Non-interventional and Mechanistic trials are excluded from the EU Directive and the UK Clinical Trial Regulations.
Non-interventional trials are not within the scope of the Regulations, i.e. those where the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorisation. In these cases the assignment of a patient to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within current practice, and the prescription of the medicine is clearly separated from the decision to include the patient in the study. Also, no additional diagnostic or monitoring procedure related to the therapeutic strategy is applied to the patients and epidemiological methods are to be used for the analysis of data.
A "mechanistic study" means a study where a medicinal product is being used but the purpose of the study is to investigate the patient or disease, not the medicinal product.