Independent Data Safety Monitoring Committee
The purpose of the TROG Independent Safety Monitoring Committee (IDSMC) is to monitor the progress of all late phase II and phase III TROG clinical trials with the aim of:
a. safeguarding trial participants by assessing the safety and efficacy of interventions begin investigated in each trial
b. monitoring the overall conduct of the trials to ensure high quality and
c. ensuring that wherever possible each trial meets its primary objectives, this being the main reason for the trial's conduct, and for the subject's agreement to consent to trial entry
The IDSMC will function independently of the Trial Scientific Committee (TSC), the TROG Central Operations Office, TROG Board, and all other individuals associated with the conduct of TROG trials including Trial Chairpersons and other members of the Trial Management Committees (TMCs).
For further information please refer to the TROG IDSMC Terms of Reference