Trial Committees

PLUSS Trial Steering Committee (TSC)

The role of the Trial Steering Committee (TSC) is to oversee all aspects of the PLUSS trial and act as the key reference group for clinical expertise to ensure the safety of the study participants. In addition, the Trial Steering Committee will be responsible for overall trial direction with the main responsibility to provide trial oversight including overall responsibility for the scientific integrity of the protocol and the assessment of study quality and conduct.

This Committee will have responsibility for monitoring trial progress with regard to:

1. Overseeing the day-to-day conduct of the trial, including safety oversight activities, and/or acting on advice from the PLUSS Data Safety Monitoring Committee (DSMC)
2. Overseeing trial progress/milestones (i.e. recruitment accruals, timelines etc.) and
3. Overseeing adherence/compliance to the protocol and adherence/compliance to good research practices.

The Chair of the Trial Steering Committee (TSC) will be Associate Professor Brett Manley.

The TSC will meet quarterly via videoconference during the recruitment phase of the study.  During the follow-up phase of the study, meetings will decrease to 6-monthly.  The TSC will meet face to face at least once annually.