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Brighton and Sussex CTU

The Brighton and Sussex Clinical Trials Unit (CTU) provides support and expertise for clinical researchers in the south east and beyond.

The CTU can support clinical research across a range of disciplines that will contribute to the evidence base for the diagnosis, management and prevention of disease. We aim to attract multi-centre, randomised controlled trials, but other well-designed studies will be considered. The Brighton and Sussex CTU is a collaboration with the University of Brighton and University of Sussex, BSMS, University Hospitals Sussex NHS Foundation Trust and the NIHR Research Design Service South East.

The team can assist in the development of funding applications, trial design (including patient-related outcomes), study management, quality assurance, data analysis, dissemination and trial close-down.

We received full registration from the UK Clinical Research Collaboration (UKCRC) in February 2023. Read the full story here.

Photo of staff standing outside on the grass together

What is a CTU?

A CTU is a specialist unit that has been set up to support the design, conduct, analysis and publication of clinical trials and other well-designed studies.

It has the capability to provide specialist expert statistical, epidemiological and other methodological advice and coordination to undertake successful clinical trials.

In addition, most CTUs have expertise in the coordination of trials that involve investigational medicinal products. These trials must comply with UK regulations that govern the conduct of clinical trials, as resulting from the EU directive.

Sponsorship

The CTU cannot act as a sponsor. Please contact your R&D Manager to ascertain who will take on the role of sponsor. Written confirmation is required for CTU support.

What do we support?

We need to ensure the following criteria are met in order to be able to provide CTU support for your project:-

Source of funding must be awarded via a competitive process with evidence of appropriate level of peer review (potentially eligible for adoption on to CRN portfolio)
Mixed portfolio of studies: multi-centred RCT (phases II-IV) and other well-designed study
RDS or evidence of similar level of methodology support provided in development of grant, including statistics
Evidence of support from a sponsor (eg University Hospitals Sussex NHS Foundation Trust, SPT)
Evidence of statistician from core CTU management team involved from design through to dissemination
Evidence of other members of CTU core management team involved in grant development as required
CTU time and support clearly budgeted
Members of CTU team involved in final publications, as appropriate (agreed at study start up).

How we can help

We can provide a range of help throughout the clinical trial process.

Find out about how we can assist with:

BACKGROUND IMAGE FOR PANEL

Current studies

Find out more information about the studies currently supported by the Brighton and Sussex Clinical Trials Unit.

Costings

CTU costs need to be included in all grant applications and approved prior to submission.

Download information on trial management >
Download information on data management >
Download information on statistical support >

Costs may include:

Statistician/statistical support costs
Trial managers/study oversight
Overheads to cover: use of data management systems, randomisations systems (if applicable), monitoring visits, travel and management of multi-centered studies

You will still need to contact the finance/award teams at your host organisation for full costing of the project.

Standard operating procedures

Standard Operating Procedures (SOPs) are written documentation of processes that require a standard of quality and consistency.

SOPs are an essential element for the control of clinical research from planning through to study closure, and for all the activities which support the clinical research process. All investigators accessing CTU support will be expected to adhere to CTU SOPs.

The advantages of a SOP system are to provide:

a standardised approach
a structure for systems development and continuous improvement
a best practice and processes in line with current legislation
an integration and training platform for individuals
a transparency in approach
an audit trail.

Example SOPs include: an SOP on SOPs • protocol development • risk assessment and monitoring • trial master file/site file (investigator and pharmacy) • regulatory approvals • trial initiation and site set up • data management • trial supplies • safety reporting/pharmacovigilance (if IMPs) • quality management systems • patient Information • training • registration/randomisation (if applicable) • statistics • IT/database • trial closure • end of trial reporting • archiving