At the meeting of Finance, Research and General Purposes Committee (FRGPC) on 4 October 2022, the following two proposals were discussed and agreed:
- A charge will be levied on commercially-funded clinical studies and trials, where the University is to be the trial sponsor, to contribute to support costs in Research Services teams (including the sponsor oversight work and responsibilities of the Research Governance, Ethics & Assurance Team (RGEA)). The relevant costing will be provided by RGEA on request and will be based on the characteristics of the proposed study or trial.
- The University requires that a University sponsored Clinical Trial of an Investigational Medicinal Product (CTIMP) or Clinical Investigation of a Medical Device (regulatory device trial) is fully managed by a UKCRC accredited Oxford CTU. In a situation where the relevant Oxford CTU(s) does not have capacity to take on such a trial, or there is a lack of relevant expertise within Oxford CTUs, use of an external UKCRC accredited CTU may be necessary. This will need discussion with RGEA and will incur a Sponsor Oversight Fee.