Table 6 Trial management committees
Committee | Role | Members | Frequency of meeting |
|---|---|---|---|
Trial Management Committee (TMC) | To monitor all aspects of the conduct and progress of the trial, ensure that the protocol is adhered to and take appropriate action to safeguard participants and the quality of the trial itself. | • Principal investigator | Weekly |
|  |  | • Trial manager |  |
|  |  | • Intervention team leaders |  |
|  |  | • Outcome evaluation coordinator |  |
|  |  | • Project coordinator |  |
|  |  | • Data manager |  |
Trial Steering Committee (TSC) | To provide overall supervision of the trial and ensure that it is being conducted in accordance with the protocol and the relevant regulations. The TSC should approve the trial protocol and any protocol amendments and provide advice to the TMC on all aspects of the trial. Decisions about continuation or termination of the trial or substantial amendments to the protocol are finally the responsibility of the TSC. | • Independent chairperson (Lakshmi Vijayakumar, a psychiatrist and trialist from Chennai) | Six-monthly |
|  |  | • Co-investigators (Betty Kirkwood, Christopher G Fairburn, Helen Weiss and Michael King) |  |
|  |  | • Members of the TMC |  |
Data Safety Monitoring Committee (DSMC) | The DSMC will review the accruing trial serious adverse event reports to assess whether there are any safety issues that should be brought to participants’ attention or any reasons for the trial not to continue. It is the only body that makes recommendations to unblind data and makes further recommendations to the TSC. | • Sunita Bandewar (anthropologist with expertise in research ethics), | Six-monthly |
|  |  | • Soumitra Pathare (psychiatrist with expertise in mental health law and human rights, member of national Mental Health Policy Group) |  |
|  |  | • Paulomi Sudhir (clinical psychologist) |  |
|  |  | • Nikhil Gupte (biostatistician, runs a clinical trials unit) |  |