Trial Steering Committees and Data Monitoring Committees

Trial Steering Committees (TSC)

The role of the TSC is to provide overall supervision for a trial on behalf of the Trial Sponsor and Trial Funder and to ensure that the trial is conducted to the rigorous standards set out in the Medical Research Council’s (MRC) Guidelines for Good Clinical Practice.

NIHR Clinical Trials Toolkit: Trial Steering Committees

NIHR Research Governance Guidelines: Trial Steering Committees and Data Monitoring and Ethics Committes

Data Management Committees (DMC)

A DMC is required for studies that are sponsored or co-sponsored by the University of Edinburgh and/or NHS Lothian.  The DMC will be responsible for safeguarding the interests of trial participants, assessing the safety and efficacy of the interventions during the trial, reviewing external evidence with an impact on risk/benefit balance and for monitoring the overall conduct of the clinical trial.

ACCORD SOPs - CR007 Study Documents and Amendments