Medical device trials

Contact the Research Governance, Ethics & Assurance Team for advice on additional costs to include in your funding application, such as:

• statistical services
• GCP monitoring and audit
• MHRA application fee
• archiving costs
   

All studies of a medical device that are governed by the Medical Device Regulations require authorisation by the Medicines and Healthcare Products Regulatory Agency. Application is via the Integrated Research Application System (IRAS) and the Research Governance, Ethics & Assurance Team will be happy to advise.

You will need to pay MHRA a standard application fee and a fee for any amendments until trial completion.
 

Journals that follow the guidelines released by the International Committee of Medical Journal Editors (ICMJE) require device trials to have been listed on an independent, free to access, validated, public register.

The trial must be registered before the first patient is recruited. Authors whose trial is unregistered will have to convince the editor that they had a sound rationale when they decided not to register their trial.

Acceptable registries include:

• clinicaltrials.gov, for which the University has an account. Please email RGEA.Sponsor@admin.ox.ac.uk if you would like an individual user account.
• International Standard Randomised Controlled Trial Number Register (ISRCTN). There may be a charge for registration. Some funding bodies require ISRCTN registration.
   

If any third party (including commercial involvement, facilities or services from an NHS trust or other university) is involved, then contracts and agreements need to be in place prior to trial start. These include:

• supply of the medical device
• funding/educational grant
• laboratory and/or pharmacy services
• out-of-hours code breaking services
• emergency medical cover
• participation of other sites (in multicentre studies)

The Medical Sciences team can help identify what agreements are required.
 

Whilst the University, as sponsor, is legally responsible for the overall conduct of your trial, the regulations allow for accountability for certain functions to be shared or delegated by written agreement.

Prior to trial start, the Research Governance, Ethics & Assurance Team will need to agree with you which functions it is appropriate to delegate to the chief investigator or other individuals or organisations.

Delegation of accountability for specific functions depends on the resources available for your particular trial and the level of experience and related training.
 

The day-to-day running of your trial will involve other staff to whom accountability is delegated by the chief investigator via a written legal agreement. Staff accepting these accountabilities must sign the delegation log, which must be filed in the trial master file/investigator site file.
 

A trial master file (TMF) should be set up as soon as there are documents requiring filing. We recommend they are filed together, in a coherent format to enable ease of access and so they are readily available for GCP monitoring, audits or inspections.

The Guidelines for Good Clinical Practice (GCP) list particular requirements for the contents of a TMF (in Section 8).
 

Design of a clear case report form (CRF) and a system for recording and storing data electronically are essential aids to GCP compliance. Whilst many researchers have access to software specially designed for the construction of databases, this is not essential for producing a compliant database.

A database should

• have a written specification (what it is intended to do) – to be filed in the TMF
• be secure but accessible by those authorised to do so
• have a clear audit trail (what data additions and amendments have been made, when and by whom)
• be validated (tested) as 'fit for purpose'
   

Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task. This applies to the chief investigator, and to any staff to whom accountability is delegated. The chief investigator is responsible for ensuring all staff are appropriately trained for their role.

Training includes the protocol, relevant SOPs and GCP training. All training must be recorded and records accessible for monitoring, inspection and auditing.

• Training for clinical researchers
   

Please refer to the MHRA website section on medical device trials and the guidance for manufacturers on clinical investigations for medical devices.