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Table 5 Trial management committees

From: The effectiveness and cost-effectiveness of the peer-delivered Thinking Healthy Programme for perinatal depression in Pakistan and India: the SHARE study protocol for randomised controlled trials

Committee Role Members Frequency of meeting
Trial management committee (TMC) Monitor all aspects of the conduct and progress of the trial, ensure that the protocol is adhered to, in particular the protocol related to the monitoring and reporting of SAEs, and take appropriate action to safeguard participants and the quality of the trial itself. Principal investigators Weekly
Site principal investigators
Trial managers
Research team leads
Intervention team leads
Data managers
Trial steering committee (TSC) Provide overall governance and oversight of the trial and ensure that it is being conducted in accordance with the protocol and the relevant regulations. The TSC must agree the final trial protocol and any protocol amendments, and provide advice to the TMC on all aspects of the trial. Decisions about termination of the trial or substantial amendments to the protocol are the final responsibility of the TSC. The TSC comprises the sponsors and funders, NIMH being the funder and LSHTM and University of Liverpool being the sponsors of SHARE India and Pakistan, respectively. Both sponsoring institutions will be responsible for individual sites. NIMH staff Monthly
Trial statistician and Data Coordinating Centre (LSHTM, UK) staff
Members of the TMC
Data safety and monitoring board (DSMB) The DSMB has been set up by NIMH, USA, to work specifically with the Global Hubs trials. The DSMB will ensure the safety of participants. The board will review and approve the study protocols, informed consent and all relevant documents and procedures. It is responsible for site monitoring and audit of the progress of the study, including recruitment and retention of participants, adverse events, SAEs and adherence to the time line of the study, and for making recommendations about the continuation, modification or termination of the study, based on the balance of adverse events and beneficial outcomes. Apart from this, the sites will submit reports twice per year with details of data collection and adverse events. NIMH staff Six monthly