First of all you need to establish who will sponsor the trial.

Will Cambridge University Hospitals sponsor my trial?

Clinical trials conducted by local investigators (Trust and University) may be sponsored by CUH or by CUH in partnership with the University of Cambridge. Please contact us as soon as possible so that we can establish sponsorship.

My trial will be sponsored by another organisation, can you help?

For those trials sponsored by other hospitals and academic institutions and where our site is just one of many taking part, please contact the R&D office directly.

For CTIMPs where you wish to have CUH as Sponsor (or CUH and the University as joint Sponsor) the Cambridge Clinical Trials Unit (CCTU) will help you with all the necessary steps for setting up a protocol, establishing necessary resources and funds, obtaining all necessary approvals, coordination and management.

Please contact the CCTU for further specific details.

In general, before patients can be recruited into a clinical trial the Sponsor must be satisfied that proper arrangements for all necessary regulatory requirements are in place:

  • Protocol (a clinical-trial specific template is available)
  • Peer review
  • Ethical approval
  • Clinical Trials Authorisation from the MHRA
  • Pharmacy review, supply and control of the IMP (investigational medicinal product)
  • The pharmaceutical company's Investigators Brochure for the drug or SmPC (Summary of Product Characteristics)
  • Radiation protection
  • Sponsorship and liability cover
  • Tissue supply issues
  • Contracts
  • Safety reporting and monitoring
  • Honorary contracts

These processes all take time and proper advance planning can save you time, trouble and money in the long run. Please contact therefore the CCTU at the very earliest stages, preferably at the planning stages of a grant proposal.