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 that all Research Nurses and all staff involved in clinical trials of investigational medicinal products (CTIMPs) 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 can offer two types of training: tutor-led and on-line training.
Tutor-led GCP courses
Half-day GCP courses are held either at the Deakin Centre or Clinical School on the Cambridge Biomedical campus. The courses provide an informal but intensive overview of the fundamentals of GCP and also introduce The Medicines for Human Use (Clinical Trials) Regulations.
We also offer a refresher course aimed at those who have taken the full course within the last 2 years as well as department specific training.
- Full training – 3 ½ hours long plus ½ hr Research Governance – cost £60
- Refresher – 2 ½ hours long – cost £30
- GCP Awareness: Documents & Data – 2 hours – £30
- Dept Specific (ex lab) – 2 ½ hours – cost £50
2020 DATES FOR TUTOR-LED GCP TRAINING
Both the full and the refresher training will run on the following dates for 2020:
- 24 November
To subscribe to a course, please download and complete the registration form below, tick the one you wish to attend and return along with the transfer of expenditure form to R&DTraining@addenbrookes.nhs.uk. For more information email Sylvie Robinson or call her on 01223 348490.
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.
Online GCP training
Online GCP training is accessible on the Epigeum website. If you have an Addenbrooke's email address, you can access the course free of charge. Please note that you must register with Epigeum before you can undertake the course. This training is organised in 5 modules:
- Protocol and Associated documents
- Applications, Agreements, Approvals
- Trial Master Files
- Conducting the trial
- Safety Reporting
Please note that you must register on the Epigeum site before you can undertake the course.If you do not have an Addenbrooke's email address, but hold an honorary contract with the Trust, please e-mail Katerina Tsartsali who can set up an account on your behalf. Please note that you must have prior approval from R&D: email R&DTraining@addenbrookes.nhs.uk or call 01223 348490 before you contact Katerina or Epigeum.
Once you have finished your course, you must send a copy of the certificates to Sylvie Robinson in R&D to ensure your training records are updated.
If you experience problems logging in, please contact Sylvie in the first instance.
GCP for labs
Laboratories that are involved in the analysis and evaluation of samples collected as part of clinical trials (drug trials) are regulated by The Medicines for Human Use (Clinical Trials) Regulations 2004.
The Medicines and Healthcare products Regulatory Agency (MHRA) has responsibility for ensuring laboratories are compliant with these Regulations. One expectation is that all laboratory staff involved in the analysis and/or evaluation of clinical trial samples have appropriate Good Clinical Practice (GCP) training. We intend to roll out GCP for labs sessions 3-4 times a year.
To subscribe to the course, please email research and development training or call 01223 348490.
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.