Monitoring
The monitoring plan for REFINE is based on a formal risk assessment and reviewed and updated as appropriate on at least an annual basis. The REFINE team conduct monitoring checks including consent, eligibility, treatment administration and safety monitoring. Any issues identified will be raised and discussed with the local team. Central monitoring processes have been expanded where possible to replace some of the activities that would normally be completed during on-site monitoring visits in light of the Covid 19 pandemic. On-site monitoring for the REFINE trial will be conducted on a triggered basis (triggers include low data return rate, poor data quality, late reporting on SAEs and critical protocol deviations). Any sites meeting at least 2 of the triggers will be considered for an on-site monitoring visit. The triggers will be reviewed by the trial team at least annually.