Table 4 The roles and responsibilities of committees during this study
Committees | Composition | Roles and responsibilities |
|---|---|---|
Data Monitoring Committee (DMC) | Principle investigator, research physician, administrator, statistician | • Understand the protocol of the study • Have clinical experience and relevant professional knowledge • Organize an initiating meeting, any other investigator meeting, and site visiting • Budget administration and contractual issues with individual centers • Randomization • Audit feedback forms and verify data • Advice for lead investigators • Organize central sample collection, analysis, and eventual destruction • Responsible for trial master file • Provide risk report to regulatory agency and ethics committee |
Steering Committee (SC) | Monitor, lead investigator, coordinator | • Agreement of final protocol • Organize investigator training • Monitor enrolment, allocation, collection of data, and completion of CRFs • Auditing study conduct and data collected in each site • Reviewing the progress of the study and if necessary agreeing changes to the protocol and/or investigators brochure to facilitate the smooth running of the study |