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. Access the tabs and links below to find out more.

IndividualsGroupsSystems

Chief Investigator

Clinical Research Network – Early contact & engagement

Research Design Service

Keele Quality Management System

SOPs 2, 3, HSCR-POL-01

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.

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.

IndividualsGroupsSystems
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. This includes, but is not limited to, activities such as contractual negotiation, database and 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. A range of individuals, groups and systems are involved throughout this stage. 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

 

Other useful links:

Once data collection is complete, the study moves into the close down phase which again involves a range of individuals, groups and systems as study reports are generated, 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

 

Other useful links: