How to determine clinical research project type
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 the proposed clinical research is within the scope of the Clinical Trials Regulations. If you remain unsure, please contact the Research Governance, Ethics & Assurance Team.
For advice on designing and conducting clinical trials, please refer to the linked pages below. For further information see the Clinical Trials Toolkit and/or contact the Research Governance, Ethics & Assurance Team.
Medical device trials that involve the use of an investigational medical device (either a non-CE marked device, or a device that has been modified or is being used for a purpose not covered by the CE mark) are subject to the Medical Devices Regulations.
A medical device is an instrument, apparatus, implant, in-vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a medicinal product or drug).
Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, or thermal means.
Please contact the Research Governance, Ethics & Assurance Team for advice on device trials.
All other clinical research that is not governed by the Clinical Trials or Medical Devices regulations will be referred to as 'clinical research studies'.
All research involving human participants, human tissue or human data (unless the data is previously collected, fully anonymised and cannot be traced back to an individual) requires approval from a NHS Research Ethics Committee (REC) prior to any study procedures taking place.
Although NHS REC review is not required for clinical research studies limited to use of previously collected, non-identifiable information, even from NHS patients, the Research Governance, Ethics & Assurance Team do need to be aware of the research and review the documents on behalf of the University. Please note that if the research is being conducted within the NHS, in England permission through HRA is needed. If however it is conducted in Scotland or Wales (or Health and Social Care (HSC) in Northern Ireland) NHS or HSC management permission for each NHS/HSC research site is needed.
The University requires that all research tissue bank (biobank) and research data bank (database) applications be submitted to an NHS REC for ethical review, with prior review by the Research Governance, Ethics & Assurance Team.
Proposal documents must be sent to the Research Governance, Ethics & Assurance Team for review before submission to a REC and/or the Human Tissue Authority (HTA). For full details, please refer to our Research using biological samples, tissue banks or data banks page.