Trial oversight
RECRUITMENT
REFINE is sponsored by UCL. The MRC CTU at UCL has overall responsibility for the study working closely with the Chief Investigator (CI), all members of the TMG and all collaborators. The Trial Management Team (TMT), comprising CI, clinical project manager, trial manager, data manager and statistician, meet weekly to discuss all aspects of trial management including site set up, recruitment and safety reporting. The TMT report to the TMG who oversee the conduct of the trial and meet formally every 6 months. The IDMC meet annually to review unblinded accumulating efficacy and safety data. The IDMC and TMG report to the TSC who provides overall supervision of the trial.