Clinical Trials & Governance Support
This section is for staff interested in becoming involved in conducting research. Lots of guidance and support is available from the earliest planning stages through to delivering the study. Help is available both for the process and for the individual wishing to develop skills in good clinical practice.
The Research Design Service (RDS)
The Research Design Service (RDS)
The East Midlands RDS provides expert advice to help local researchers to develop and design high quality research proposals for submission to national, peer-reviewed funding competitions for applied health or social care research.
It is part of the National Institute for Health Research (NIHR) infrastructure and is a national service regionally delivered working to the maxim "consistency where possible, flexibility where appropriate". The support is provided free of charge.
Research Ethics
Much health-related research involving human participants requires ethical approval. The National Research Ethics Service (NRES) is a core function of the Health Research Authority, established towards the end of 2011. Its mission is to protect the wellbeing and safety of research participants and promote ethical research for the benefit of participants, science and society.NRES provides an ethical review service of all UK clinical research, and runs Research Ethics Committees throughout England. Their website publishes a Directory of Guidance for researchers and gives advice on defining what requires ethical approval. It also has a number of other useful publications.
Clinical Trials Units
High quality clinical trials units (CTUs) that have expertise in centrally coordinating multicentre clinical trials, as well as in trial design, data management, and analysis are registered with the UK Clinical Research Collaboration (UKCRC), backed by the National Institute for Health Research (NIHR).The UKCRC website lists registered CTUs across the country, which can searched by location and other criteria, such as experience in specific disease or methodological research areas.
Registered CTUs in the East Midlands are the Leicester Clinical Trials Unit and the Nottingham Clinical Trials Unit.
Clinical Trials Toolkit
The Clinical Trials Toolkit was established in 2004 to document best practice in public and charity-funded clinical trials of medicines. It is primarily for clinical trialists and R & D Managers working in the academic sector, but is also of use to other health professionals. It provides route maps to help navigate through regulatory requirements and gives useful information about clinical trials.Clinical Research Networks
These provide the infrastructure to support clinical research that is eligible for the Clinical Research Network Portfolio. They help with study planning, advising on NHS study sites, suggesting clinicians who may want to be involved and providing intelligence on local patient populations. They also help with gaining permissions to deliver the study, utilising the Co-ordinated System for Gaining NHS Permission (CSP) and in delivering the study (accessing NHS facilities and equipment; also trained research support staff)
The website for the UK Clinical Research Collaboration (UKCRC), backed by the National Institute for Health Research (NIHR), provides links to clinical research networks by region. Networks in the East Midlands are listed below:
- NIHR Comprehensive Research Networks
- Cancer Research Networks
- Diabetes Research Network
- Medicines for Children Research Network
- Mental Health Research Network (offers a useful toolkit including form and agreement templates that can be adapted as needed)
- Primary Care Research Network
- Stroke Research Network
Good Clinical Practice
Training in Good Clinical Practice (GCP) is a key requirement for anyone involved in the conduct of clinical research. GCP is the standard and guidelines to which all research is conducted.
The NIHR offer training online and face-to-face. They also offer a number of GCP tools and resources, including general log, tracking and checklist tools, information on regulations, contractual agreements, abbreviations; also information specific to research involving children and adults lacking capacity.