Clinical device trial planning
Sponsorship and ethics applications
Sponsorship is required for all Clinical Research under the Research Governance Framework(s), including trials that fall within the scope of the Clinical Trial or Medical Device Regulations. Identification of the Sponsor must be considered early in the planning process. Where the Chief Investigator is employed by OUH, the Trust will usually act as Sponsor.
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 Research Ethics Committee (REC) prior to any study procedures taking place.
Specific funding requirements
You should contact the OUH R&D Department as early as possible in the planning of your Medical Device Trial.
OUH R&D Department - Contact us
The R&D finance team can advise on additional costs to be incorporated into your funding application, for example:
- statistical services
- GCP monitoring and audit
- MHRA application fee
- archiving costs.
Notification of a Clinical Investigation
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 OUH R&D Department will be happy to advise.
You will need to pay a standard application fee and a fee for any amendments submitted after the initial approval until trial completion.
Protocol registration
Most journals require many studies to have been listed on an independent, free to access, validated public register.
These include:
- trials whose primary purpose is to affect clinical practice
- trials providing evidence of clinical effectiveness or adverse effects
- investigations of the biology of disease
- collection of preliminary data that may lead to larger clinical trials
- device trials.
The trial must be registered before the first patient is recruited.
Acceptable registries include:
Agreements
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).
OUH R&D can help identify what agreements are required. The OUH contract team will help put these in place.
OUH R&D Department - Contact us
Delegation of Sponsor functions
Whilst the Trust, 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, OUH R&D will need to agree with you which functions it is appropriate to delegate to the Chief Investigator or other individuals/organisations. Delegation of accountability for specific functions depends on the resources available for your particular trial and the level of experience and related training acquired.
Delegation within the Study Team
The day-to-day running of your trial will inevitably involve other staff to whom accountability is delegated by the Chief / Principal 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.
Trial Master File
The Regulations require a Trial Master File (TMF) to be kept for a clinical trial. It should be set up as soon as there are documents requiring filing. R&D 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 Guideline for Good Clinical Practice (GCP) (Section 8) lists particular requirements for the contents of a TMF.
Guideline for Good Clinical Practice (pdf) - www.ich.org
A GCP compliant Trial Master File contents page is available, and can be adapted as required.
Clinical Trial (CTIMP) Preparation - researchsupport.admin.ox.ac.uk
All study documents should be version controlled by number and date.
Data management and Case Report Form design
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 to authorised users
- have a clear audit trail (what data additions and amendments have been made, when and by whom)
- be validated (tested) as 'fit for purpose'.
Training
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 / Principal 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.
OUH R&D and the Clinical Trials and Research Governance (CTRG) Team jointly organise GCP training days on a regular basis. Contact the CTRG administrator for details.
Clinical Trials and Research Governance (CTRG) Team - researchsupport.admin.ox.ac.uk
In addition, an online GCP course is available free to employees of OUH and the University of Oxford, or anyone working on a study sponsored or hosted by either organisation.
OUH requires that staff refresh their GCP training every three years.
Further information
Please refer to the MHRA website section on Medical Device Trials and the guidance for manufacturers on clinical investigations for medical devices.