Research pathway

The information on this page is aimed at those developing and undertaking research who want to better understand the support and guidance offered by Keele Clinical Trials Unit (CTU) and the wider National Institute for Health Research (NIHR) infrastructure.

To access further information and guidance about the range of individuals, groups and systems available to support you throughout the stages of a research project, click on the tabs below.

Taking your research idea and developing a deliverable research study capable of attracting research funding is challenging. Understanding roles and responsibilities, including development of a research team capable of delivering the proposed research, and the support structures available is an important part of this process.

We will help you develop your strategy to answer the research question(s) you have. This will include consideration of the research methods, for example individual randomised trial or a cluster randomised trial, recruitment, sample size calculation, data collection and statistical analysis.

Access the tabs and links below to find out more.

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Chief Investigator

Clinical Research Network – Early contact & engagement

Research Design Service

Keele Quality Management System

SOPs 2, 3, HSCR-POL-01

Keele CTU can work with you to develop your study protocol and funding application, advise on research design as well as offering operational guidance.

Other useful links:

Clinical Trials Units (CTUs) are specialist units with specific remits to design, conduct, analyse and publish trials and other clinical research. CTUs provide specialist methodological advice and support and have expertise in the coordination and regulation of research.

Keele CTU offers significant experience and expertise in the coordination of multi-centre trials in primary and secondary care settings. Trial management staff are supported by a dedicated administration team and can provide valuable and practical advice on research proposals. In addition, the CTU has strong links with local and national Clinical Research Networks and NHS partners to support the identification of and feasibility at sites.

Not all research studies require the support of a CTU but by clicking on the links below you will be helped to understand when a CTU might be required and how to access the support of Keele CTU.

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Senior Trials Manager

Keele CTU Adoption Group

Keele CTU Think Tank

Keele Quality Management System

SOP 3

Other useful links:

Once funding is secured, the complex process of study set-up begins. A dedicated CTU team, with support from a range of specialist working groups will work with you to set the study up. This process includes, but is not limited to, activities such as contractual negotiation, software development for data capture and study management, health informatics development, securing outcome measure permissions, seeking and gaining the necessary sponsor and regulatory approvals, including ethical approval, and identifying, training and initiating recruiting sites.

Access the tabs and links below to find out more.

IndividualsGroupsSystems

Research Projects Administrator

Study Coordinator

Trials Manager

Senior Trials Manager

Keele CTU Operations Group

Keele Quality Management System

SOPs 2, 5-7, 10-12, 18-20, 24-27, 29, 32, 33, 39-41, 45
SOSOP01, FWK01

Health Research Authority (for regulatory approvals)

Medicines & Healthcare products Regulatory Agency

Other useful links:

Once the study is set-up and the necessary approvals gained, the study can begin to recruit participants and collect data. This requires ongoing coordination and oversight involving a range of different individuals and groups within established quality assurance systems. Access the links below to find out more.

IndividualsGroupsSystems

Research Projects Administrator

Study Coordinator

Trials Manager

Senior Trials Manager

Keele CTU Operations Group

Trial Management Group

Trial Steering Committee

Data Monitoring Committee

Keele Quality Management System

SOPs 8a-9, 14, 20-22, 28, 46, 47
SOSOP02

 

When recruitment begins the CTU provides a randomisation service, will monitor and support sites, facilitate data collection and co-ordinate study management and oversight.

Other useful links:

Once data collection is complete, the CTU will support the close-down phase which again involves a range of individuals, groups and systems as data analysis by specialised statisticians, study reports are generated, including preparation of manuscripts for publication, research findings disseminated, and data archived. Access the links below to find out more.

IndividualsGroupsSystems

Research Projects Administrator

Study Coordinator

Trials Manager

Senior Trials Manager

Keele CTU Operations Group

 

Keele Quality Management System

SOPs 15-17, 42-44

 

Keele CTU can provide an on-site storage facility for the safe and secure storage of studies whilst active. It can also facilitate the archiving process of your study and ensure the provision of secure and appropriate archiving of both paper and electronic study essential data is maintained and managed appropriately, in accordance with the regulatory/funders requirements of the study. In addition, the CTU can facilitate requests for retrieval of archived data in an efficient and appropriate manner.

Other useful links:

Find out more via our online brochure

Keele CTU Brochure (5,780 KB)