Leicester Clinical Trials Unit
Collaborate with us
Planning a trial and want to work with LCTU? The steps below will guide you through the process.
Timelines
It is recommended you contact LCTU as early as possible once you have decided to apply for funding. This enables a true collaborative approach to be employed during the funding application stage and ensures you have access to the expertise of LCTU.
Please note in rare situations, an investigator may approach LCTU once funding has been secured where there has been no prior discussion. In these circumstances consideration will be made if this is a collaboration that can be supported using the process described below.
Stage One - Initial contact
Working with LCTU begins with the completion of a LCTU Collaboration Request Form (Word, 98kb). You then email the form to LCTU, along with any other documents/information which may be useful to understand your trial needs.
Your enquiry will be responded to at the earliest opportunity. Initial discussions between you and representation from the Senior Management team will determine if your application is potentially suitable for support. Further meetings will be held on an on-going basis, should your collaboration be considered to be a study that LCTU can support. If your trial cannot be supported at this stage you will be notified and an explanation given.
Stage Two - Initial LCTU collaboration discussion
The initial meeting is set up to decide whether LCTU can support the trial. It is important that the focus is on the key information. It also provides you with the opportunity to consider, at that point, whether LCTU are the right choice for you.
Example discussion areas:
- LCTU role and collaboration
- LCTU costing process
- Confirmation of funder and submission deadlines
- Involvement of other stakeholders – sponsor, RDS, CRN
- Study overview or plan
- Study timelines
- Brief overview of trial design and methodology
- Next steps
Stage Three - Trial support
Once collaboration is agreed, the Terms for Collaboration will be signed by all partners. The aim is to always provide full trial support.
Further meetings will be arranged during the application/protocol development process. These may include other potential collaborators including the East Midlands Research Design Services as applicable. Involvement at this early stage will determine the level of LCTU collaboration, that the application is costed appropriately and that the study design and statistical analysis is appropriate to answer the outcome measures and research question(s).
Stage Four - Funding approved
On receipt of the funding award, LCTU will undertake the research activities as defined in the bid. A costing letter will be provided detailing the services to be provided and their associated costs. A contract or service level agreement will be put in place before services commence.