Table 4 Study management and committees

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.

• Principal investigator from each hub^a

• Trial coordinators

• Project administrator

• Data coordinator

Weekly^b

Investigator and Advisory Committee

To monitor all aspects of the conduct and progress of the trial, including site-specific safety protocols within and across sites

• All investigators

• Research coordinators from each site

• Data coordinator

Biweekly to Monthly

Stakeholder Advisory Committee (SAC)

To provide overall supervision of the trial and ensure that it is being conducted in accordance with the protocol and the relevant regulations. The TMC 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 TMC.

• Members of the TMC

• All investigators

• Trial/content advisors and consultants

• All stakeholders

Six-monthly

Data Safety Monitoring Board (DSMB)

The DSMB 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 TMC.

• Four members (clinical psychologist, obstetrician, perinatal psychologist, a statistician) with expertise randomized controlled trials assessing psychological treatments and perinatal populations

Six-monthly