We are responsible for overseeing all the biomedical research which takes place on our campus in so far as it involves our patients, their data or tissues, or where it uses NHS facilities and our staff.
Biomedical research taking place with patients at Cambridge University Hospitals includes the following activities -
- testing a new formulation of a drug therapy
- testing a new device or tool to either improve diagnosis or to improve recovery
- testing a new method of delivery of a drug or treatment
- asking patients to complete qualitative questionnaires
- asking patients to take part in a series of tests, e.g. measuring their heart rate and recording the results
Any research involving patients at the hospital means that you will need the help of the research and development governance team. This team will guide you through the research application process to ensure that what you do is safe, ethical and complies with all the necessary legislation governing research on people.
To facilitate excellence in medical research by providing helpful and competent support on all matters of research governance, administration and management.
Before you start
Health research authority (HRA)
The role of the health research authority (HRA) is to protect and promote the interests of patients and the public in health research and to streamline the regulation of research. The HRA are also responsible for the NHS research ethics Committees.
HRA Approval is required for all research to commence in the NHS in England. It comprises a review by a Research Ethics Committee (REC), and an assessment of regulatory compliance and related matters undertaken by HRA staff located in centres around England.
HRA Approval includes a study-wide review in line with UK-wide agreed standards and also new assurances, including the coordination of clinical support assurances for radiation and pharmacy. When HRA Approval is fully implemented, sites have to confirm they have the capacity and capability to undertake the study. Once HRA Approval is in place and local capacity and capability is agreed, sites can confirm with the sponsor their readiness to recruit and the study can then start at that site.
Applications for HRA approval are made using IRAS (Integrated Research Applications System) and are e-submitted directly to the HRA through IRAS. Study documents to sites are provided directly from the sponsor for most study types. HRA studies will not appear in the NIHR CSP module.
Guidance is available on the HRA website. This includes guidance for applicants and NHS organisations and illustrative examples.
Please email the research development department with any enquiries.
The application forms for the submissions to all review bodies can be completed through the Integrated Research Application System (IRAS). This national on-line system captures all the necessary information for the relevant approvals. It replaced previous forms such as the NRES form and COREC form.
The key IRAS forms are:
- REC application form
- R&D application form
- Site specific information (SSI) form
Once ready, the forms can be signed electronically and submitted to the applicable review bodies.
Good Clinical Practice (GCP) training
It is Trust policy for all Research Nurses and all staff involved in clinical trials of investigational medicinal products (CTIMPs) to complete GCP training. The Trust accepts certification of training done in the last two years. For any member of staff who has not completed GCP training within the last two years, the R&D Department currently offers online training (see below). Face-to-face training is not currently available, in line with current guidance.
Full sessions are now online via Epigeum or the NIHR:
The access method for the online GCP training has changed. The platform you used previously to register is no longer active. You will now be set up directly by Aslihan Yener (firstname.lastname@example.org). Once set up, you will receive a confirmation email from R&D with an attached User Guide and an automated email from Epigeum inviting you to complete your registration profile and activate your account.
The course covers 5 modules. Each module has a test with a pass mark of 75%. A certificate is delivered at the end of each course:
- Course 1: Protocol and Associated Documents
- Course 2: Application, Agreements and Approvals
- Course 3: Trial Master Files
- Course 4: Conducting the trial
- Course 5: Safety Reporting
Visit their website for more details on GCP training: https://www.nihr.ac.uk/health-and-care-professionals/learning-and-support/good-clinical-practice.htm.
Refresher / lab sessions dates for 2021:
For refresher and lab sessions, a series of live webinars led by our trainer Shirley Hallam has now been set up. Dates are below. Each session will run for 2 hours from 09.00 to 11.00.
GCP update refresher:
- Thursday 14 January 2021
- Tuesday 16 March 2021
- Thursday 20 May 2021
GCP for Laboratories:
- Tuesday 20 April 2021
Certificates will be delivered at the end of the session or shortly after.
Once you have completed your course, please send a copy of the certificates to Aslihan Yener in R&D to ensure your training records are kept up-to-date.
The Transfer of Expenditure form allows direct transfer of funds between a Trust department to another only for employees of Cambridge University Hospitals NHS Foundation Trust. If this does not include you and you would like us to invoice your department, then you will need to mark your registration form accordingly (i.e. non CUH NHS FT) and provide us with your departmental budget holder, tel no, email and postal address.
If you can provide us with a Purchasing Order please do; it is however not compulsory unless your department requires it.
Remote EDGE training
Local Portfolio Management System (LPMS)
Since 2017 Cambridge University Hospitals (CUH) have been using an LPMS called Edge to capture clinical trials data and support the delivery and maintenance of research at CUH.
If you work on studies adopted to the NIHR Portfolio, it is a mandatory requirement to upload patient recruitment data to Edge.
LPMS / Edge data now feeds and flows directly to the Central Portfolio Management System (CPMS)
Edge covers Portfolio study recruitment only
Remote training now available
Face-to-face training in using Edge unfortunately is unable to take place during the current pandemic, but the Edge team can now offer virtual training over Zoom. This lasts around an hour and is suitable for all NHS staff with responsibility for confirming recruitment activity from EDGE in CPMS.
If you are interested in taking advantage of this opportunity, either for yourself and/or team members, please contact the CUH EDGE Team at CUHedge@addenbrookes.nhs.uk in the first instance, with proposed dates and times that work for you.
Starting a project
If you are thinking about starting a research project, take the opportunity to speak to the research development department as early as you can, even if all you have is an idea.
They can offer advice and help with protocol submission and advise you on what information you will need to submit a research application.
Setting up a project
Once a project has been authorised to take place at the trust, the R&D Department provides ongoing support for investigators and is happy to answer queries on all aspects of research.
The pages in this section will provide advice and guidance on the various elements involved in research especially in the early stages of study set-up. This can include providing training, issuing honorary research contracts or letters of access, or even providing funding guidance for grant applications. We also have an innovation scout within the department to help you with any innovations queries.
National Institute for Health Research (NIHR)
The National Institute for Health Research's vision is to improve the health and wealth of the nation through research. Visit the NIHR website to find out more about funding opportunities, including funding for research studies and training/career development.
NIHR Research Design Service East of England
Thinking of applying for research funding? The Research Design Service for the East of England offers free advice on all aspects of preparing grant applications and building collaborative research teams, including:
- Sources of funding
- Refining research objective
- Designing your study
- Methodological expertise
- Planning research teams and budgets
- Patient and Public Involvement
To find out more about current funding opportunities visit the RDS East of England website.