UCL PRIMENT Clinical Trials Unit

UCL Priment Clinical Trials Unit

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Working With Us

PRIMENT CTU collaborates with researchers in higher education, the NHS and industry to develop and/or evaluate complex interventions in primary care, psychiatric and community settings. The collaboration should begin in the early stages of protocol development and continue to study closure and dissemination of results.

• Requesting PRIMENT collaboration
• Trial development and funding application
• Trial implementation
• Analysis and dissemination

Requesting PRIMENT collaboration

Collaboration with PRIMENT on your grant application requires the inclusion of a PRIMENT trialist, statisticians and, where applicable, a health economist for the duration of the trial and dissemination of results. This ensures that PRIMENT is able to work effectively with your team and satisfies the requirement of most major funding bodies that a registered CTU is closely involved in your trial. PRIMENT should be involved in a grant application as early as possible to allow contribution to the study design process.

To request to collaborate with PRIMENT a request form must be completed (download from the link below) and submitted to the PRIMENT administrator with a draft of the protocol or grant application form. The PRIMENT steering group review each request and make a decision on whether to adopt the study.

Collaboration requests should be received at least 6 weeks (and ideally 12 weeks) in advance of the grant submission deadline.

• PRIMENT Collaboration Request application form - download

The process for obtaining confirmation of PRIMENT collaboration is outlined below.

Trial development and funding application

When PRIMENT has agreed to collaborate on a study the PRIMENT staff allocated ot the project meet with the CI and study team to clarify details of the protocol, such as the trial population, trial design, details of the intervention and the comparator, outcomes of interest and analysis plan. 

When funding for the study has been confirmed PRIMENT members provide further input, for example: reviewing and finalising the trial protocol and the analysis plan, finalising the randomisation procedures, operationalising the research, developing data collection forms and trial manuals, database development, providing guidance on ethics and local NHS R&D applications and assisting with the Clinical Trial Application (CTA) if necessary.

PRIMENT can also provide support in the following areas: Project management, financial planning, quality assurance, quality control, IT support and administrative support.                                                                                                                                     

Trial implementation

PRIMENT staff continue to be involved in a study throughout the implementation stage and their input may include: Maintaining an overview of recruitment and randomisation, having an overview of the development of reports for the Data Monitoring (DMC) and Trial Steering Committees (TSC), monitoring attrition rates and carrying our appropriate data checks during follow up.

Analysis and dissemination

Towards the end of a trial PRIMENT can provide assistance with overview and supervision of the data cleaning and the analyses and the preparation of the final trial report and publications. PRIMENT maintains responsibility for data management and has further interactions with DMC and TSC. PRIMENT's contribution to final publication is required.