Monitoring and Supervision
The Trial Steering Committee (TSC) provide supervision on behalf of the Trial Sponsor (University of East Anglia) and the Trial Funder (NIHE EME) and to ensure that the trial is conducted as set out in the Medical Research Council's (MRC) Guidelines for Good Clinical Practice.
The Data Monitoring and Ethics Commitee (DMEC) monitor un-blinded comparative data and make recommendations to the TSC on whether there any ethical or safety reasons why the trial should not continue based on the available data.
The Trial Management Group (TMG) meet every 3 months and provide strategic oversight of the trial and will be composed of members the trial team and service users. Three Local Management Groups (LMGs) in Birmingham, Staffordshire, and Norfolk meet for two months of a three month cycle to provide operational management of the trial. On the third month the Trial Management Group will meet in its place.