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Information required to assess sponsorship

As with any new sponsorship request that the University is asked to consider, we use the lessons learned from previous requests to ensure that the decision to sponsor a trial - in principle – is carefully considered. In order to achieve this we require maximum information and in a timely manner related to the trial. This approach helps avoid any delays further down the line. The CI should consider the following list to help us complete any sponsorship request.

  1. Confirmation of who the CI is for each trial and provide a copy of their CV (updated within the last 2 years)
  2. Confirmation of the clinical trial phase for each trial
  3. Confirmation the proposed study is classed as a CTIMP if applicable
  4. A trial protocol to enable the sponsor to risk assess the trial and categorise the potential risk associated with the IMP (Type A, B or C)
  5. Confirmation of engagement with a statistician and statistical review 
  6. Confirmation of a data management plan
  7. Confirmation of peer review and Faculty approval
  8. Details of costings carried out to date; costings must include costs for a clinical trials unit involvement, costs for MHRA fee, archiving costs, costs for the IMP and placebo, pharmacy costs, Sponsorship costs - please provide copy of the Costings/Pure form (FBMH)
  9. An outline of trial timelines from idea to archiving, including all submission deadlines
  10. Confirmation that the lead NHS R&D site has agreed to host the CTIMP(s) and confirmation of other host organisations
  11. The name of the proposed lead pharmacist and evidence of in principle acceptance by the pharmacist and the pharmacist's employer
  12. Confirmation of vendors likely to be used in the trial and confirmation (at least in principle) of what activity they will be providing (e.g. CTU, IMP distributor, randomisation service, GMP facility, Laboratories) - each vendor to be listed separately
  13. Proposed archiving arrangements and costs

Where you are using a CTU, the University will likely require the following information:

  1. A complete list of activities the CTU has agreed to provide for the trial (please point out any cost related activities the CTU has not agreed to carry out)
  2. Confirmation regarding the level of trial management that the CTU will provide and what the CTU expects the sponsor/CI to undertake
  3. Confirmation of the IMP costs, including any manufacturing, labelling, distribution and storage costs the CTU has provided for this trial
  4. Confirmation of who the lead pharmacist for this trial is as agreed with the CTU, including their role and responsibility
  5. Confirmation of the proposed level monitoring for this trial as agreed with the CTU
  6. Any issues the CTU has raised for this application that remain unresolved 
  7. Any issue where in the opinion of the CTU there is a lack of clarity e.g. is there an activity that hasn’t been considered, costed or there is uncertainty who is or should be providing the activity