Research

We are currently involved in over 100 clinical trials and other studies ranging from testing new surgical devices to trialling new drugs.

However, research projects cannot get started without the participation of our patients. We rely heavily on the thousands of patients we treat every year to volunteer and take part in research projects.

This arrangement is mutually beneficial because we get to see how new treatments work in practice and our patients benefit from ground-breaking treatments earlier than they would otherwise.

The Research Office is heavily involved in Clinical Research and actively involved with listed National Institute for Health and Research’s (NIHR) portfolio, a national information point of studies being run across the UK.

Research trials

At the heart of the Clinical Research Network’s activities is the NIHR Clinical Research Network (NIHR CRN) Portfolio of studies. This consists of high-quality clinical research studies that are eligible for consideration for support from the Clinical Research Network in England.

Research activity (recruitment) data from the NIHR CRN Portfolio is used to inform the allocation of NHS infrastructure for research (including NHS Service Support Costs) and supports the performance management of the Clinical Research Network.

UK Clinical Research Network Portfolio of Studies

The NIHR Clinical Research Network Portfolio is part of the UK Clinical Research Network Portfolio of studies, which comprises the network Portfolios for England, Northern Ireland, Scotland and Wales. These four Portfolios are held on a single information system: the Central Portfolio Management System (CPMS).

For information on available trials visit NIHR Be Part of Research website.

Taking part

If you are treated at one of our hospitals, you may be invited to take part in clinical research. It is entirely up to you whether or not you wish to be involved. If you decide not to participate, you will still be treated with the best care currently available.

The length of time each study takes and what you’ll need to do varies depending on what is being investigated and on the specific tests and measurements that are needed. Some trials may involve overnight stays, or making additional visits to hospital. The research staff will also explain this to you along with the eligibility and screening. Patients from hospitals outside our Trust can take part in our trials dependent on eligibility criteria but would need referral to a specialist team at our hospitals.

Standard Operating Procedures (SOPs)

Chief and Principal Investigators, all other research personnel who have been delegated roles and responsibilities and the staff of the R&D Department who have the function of research governance for our hospitals must adhere to this set of procedures when undertaking research:.

• SOP 01 Preparation of SOPs
• SOP 02 Research Documentation and File Management
• SOP 03 Training
• SOP 04 Informed Consent in Research
• SOP 05 End of Trial Procedures
• SOP 06 Trial Archiving
• SOP 07 Managing Participant Expenses
• SOP 09 Medicines Management
• SOP 10 Hosting CTIMPs and other Clinical Studies
• SOP 11 Confirmation of Capacity and Capability
• SOP 14 Study Income Distribution
• SOP 15 Research Studies Involving Sue Ryder
• SOP 16 Managing MHRA Inspection
• SOP 17 Radiotherapy trial management at satellite sites
• SOP 18 Application Process for an Honorary Contract, Letter of Access or Research Passport
• SOP 19 Periodic Safety Reporting
• SOP 20 Adverse events and reaction safety reporting
• SOP 24 Scientific Peer Review
• SOP 25 Staff Surveys
• SOP 29 Writing a protocol

Guidelines

• Guidelines 01 - External Monitor Access to Sunrise EPR
• Guidelines 02 - Using the non-CTIMP template protocol

Frequently Asked Questions (FAQs)

More information on research at our hospitals is available here

Working in partnership

National Institute for Health Research

They are funded by the Department of Health to improve the health and wealth of the nation through research.

Read more about the National Institute for Health Research

University of Gloucestershire

Each of the eight academic schools contribute to their learning-led, research-informed environment. They embed research in all activities, ensuring students and staff benefit from and contribute to vibrant subject communities, engaged in fundamental and applied research.

Their research priority areas build on strengths and recognise the opportunities to contribute to contemporary challenges which include:

• Sport, exercise, health and well-being
• Environmental dynamics and governance
• Being Human: past, present and future
• Innovation, design and technology
• Applied business research
• Learning from professional contexts

Read more about the University of Gloucesteshire

West of England Clinical Research Network

As the NIHR Clinical Research Network, West of England, they help to increase the opportunities for patients to take part in clinical research, ensure that studies are carried out efficiently and support the Government’s Strategy for UK Life Sciences by improving the environment for commercial contract clinical research.

Read more about the West of England Clinical Research Network

Research Design Service (RDS)

Each RDS office is run by an experienced researcher, well-equipped to provide practical and user-friendly advice on the research process and on applying for funding.

For further information on who they are and how they can help, visit: www.rds-sw.nihr.ac.uk

Good Clinical Practice (GCP)

Everyone involved in the conduct of clinical research must have training in Good Clinical Practice to ensure they are best prepared to carry out their duties. This is laid down in the Research Governance Framework for Health and Social Care 2005, covering all research in the NHS in England, and in law for those people working on clinical trials.

The principles of GCP state that: Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s), 2.8, E6 Guideline for Good Clinical Practice.

To download a copy of the NIHR Training Programme for GCP visit NIHR CRN Training Programme.

The team