Running the trial

Once funding is confirmed, we will work closely with you to finalise the protocol and prepare submission documents for ethics review and, where required, MHRA approval. All documents will be developed promptly, in line with the agreed budget, relevant legislation, and good clinical practice standards. We will carry out a risk assessment to support smooth, compliant trial delivery.

At the same time, we will set up study sites for recruitment, establish supply arrangements, and implement data management and safety reporting systems. We will also ensure that essential Trial Master File documentation is in place. Where needed, we will coordinate with other University teams, including contracts and the sponsor office, to keep processes on track.

A strong partnership between the Chief Investigator and the trial management team is vital. Clear, regular communication allows us to address issues quickly and respond to new opportunities as the trial progresses.

Throughout the study, you will receive regular reports on recruitment, data quality, and other key metrics to provide assurance of safe and compliant trial delivery.