If you are planning a trial, please review the following information and documents:

First steps

Either

• Telephone the CTU to discuss your proposed trial in the first instance, or
• Send an outline proposal to the CTU, ideally together with the UKCRC CTU collaboration request proforma, providing as much detail as possible on your trial design, current status and anticipated support needs.

Meeting the CTU team

A meeting can be arranged at the CTU with all relevant staff.

The meeting may also include other potential collaborators and the Research Design Services as applicable. The RDS is funded to provide expert advice to help local researchers develop and design high quality research proposals for submission to national peer-reviewed funding competitions for applied health or social care research.

The CTU needs to be involved at this early stage to ensure that the study proposal is developed and costed appropriately for trials unit activities, and the study design and outcome measures are appropriate for the planned statistical analysis.

The CTU will therefore provide help with trial design and input to the grant application. For further details, see the Leicester CTU presentation. If the Leicester CTU decides that it cannot help, e.g. because of timing or lack of appropriate resource, it will make every effort to help the investigators to target alternate support.

Funding approved

On receipt of the grant award, the CTU will undertake the research activities as defined in the bid we helped to prepare and as applicable to the grant award specifications.

In rare situations, an investigator may approach the CTU once funding is in place where there has been no prior discussion with the trials unit. The CTU will help to define how support can best be provided at this stage. Trial work up or development of research activities or service provision will be provided as applicable.

Overview of CTU involvement

The figure illustrates standard trial processes and the potential involvement of the Leicester CTU at the various stages from reviewing an outline proposal, through trial development and management, to analysis and reporting.