Within the University it has been agreed and made policy through the Finance, Research and General Purposes Committee (FRGPC) that any regulated medical device trials or drug trials, which are to be sponsored by the University, must be run through one of the University’s 5 UKCRC Registered Clinical Trials Units (CTU).
Note: A regulated trial is a trial that requires approval (authorisation) from the UK Competent Authority (known as the Medicines and Healthcare products Regulatory Agency (MHRA)).
How do you know if a trial will be a regulated drug trial (known as a CTIMP – a clinical trial of an investigational medicinal product)?
If there is any uncertainty, please discuss with Research Governance, Ethics & Assurance (RGEA) for advice.
If you are in trials unit and are reviewing a proposal, check how the question– ‘Is a Clinical Trial Authorisation required?’ has been answered in the grant application. This will indicate if a trial has been considered to be a regulated drug trial by the study team. If there is a discrepancy, discuss with Research Governance, Ethics & Assurance and the study team.
How do you decide if a trial is a regulated device trial?
Unfortunately, there is not yet an equivalent algorithm to inform whether a trial is a device trial that will need to be regulated. Trials that include in-house developed software, and/or devices that can range from a bandage to a new implantable device and items in-between can all be classed as regulated medical device trials.
Note: There will still be many clinical trials that do not require MHRA approval and these trials can be run in departments without the need to engage with one of the registered CTUs. Trials that include a drug or a device may not fall within the scope of needing MHRA approval.
As this is an area where the rules are less certain, it is especially important to engage early with CTUs and RGEA to ensure you have a common understanding of the status of your proposed trial (see below).
Which are the registered CTUs approved to run regulated Drug and Device Trials?
Currently there are 5 UKCRC Registered Clinical Trials Units. These are:
- Clinical Trial Service Unit (CTSU), based in Nuffield Department of Population Health
- Diabetes Trials Unit (DTU), based in Radcliffe Department of Medicine
- National Epidemiology and Perinatal Unit (NPEU), based in Nuffield Department of Population Health
- Oxford Clinical Trials Research Unit (OCTRU), based in Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
- Primary Care and Vaccines Collaborative Clinical Trials Unit (PCVC-CTU)
How should contact be made with these units?
You should make contact with the most appropriate unit based on the trial design/area of medicine. Units have different processes for trial adoption so early discussion is key. For trials that are adopted you should ensure that costings from the CTU are added into the X5 by the applicable host department of the CTU.
Note: The registered CTUs are not obliged to take on every study, therefore you should engage in CTU discussions very early in the development of grants or proposals.
What to do if after reading the above you are unsure whether the research/trial proposed does include a regulated trial?
If you are unsure as to whether the proposed trial might be classed as a regulated trial and therefore need MHRA approval, and consequently CTU support, you should make contact with RGEA to discuss the trial and ask for their opinion on classification on firstname.lastname@example.org .
Note: Sponsorship will not be agreed by the University Research Office (RGEA)) if regulated trials are funded but no agreement is in place to conduct the study in a registered CTU in Oxford.