Data monitoring, safety and quality control
ADVERSE EVENTS, EVENT
An independent TSC and independent Data Monitoring Committee (iDMC) have been appointed. The main role of the TSC will be to provide overall supervision of the trial and ensure that it is being conducted in accordance with the principles of Good Clinical Practice and the relevant regulations. The main role of the iDMC will be to safeguard the interests of trial participants and to monitor the main outcome measures including safety and efficacy. The clinical trial manager, together with the Trial Management Group, will oversee trial progress.All treatment-related AEs (related to the GCS only) will be collected centrally at 7 days postprocedure, as will all serious adverse events (SAEs). The Chief Investigator (CI) will be notified of all SAEs within 24 hours. All SAEs will be reported to the Research Ethics Committee (REC) and sponsor if, in the opinion of the CI, the event was related to the intervention. These analyses will be descriptive, with any p values calculated to be interpreted descriptively.