Trial Oversight


 

Ensuring Compliance, Patient Safety and Data Integrity.

Trial Steering Committee

Is responsible for oversight of the trial in order to safeguard the interests of trial patients. The TSC is comprised of a 75% majority of independent and lay members, as well as the Chief Investigator, representatives of Principal Investigators, a representative of the sponsor, the health economist and senior trial statistician. The committee provides advice to the Chief Investigator, UCL Comprehensive Clinical Trials Unit, the funder and sponsor on all aspects of the trial through its Independent Chair.  The remit of the TSC is to oversee study conduct and advise the TMG.

 

The Trial Management Group

Is responsible for the day-to-day management of the trial, including monitoring of all aspects of the conduct and progress of the trial, ensuring that the protocol is adhered to and taking appropriate action to safeguard participants and the quality of the trial itself.

 

Independent Data Monitoring Committee

Is the only oversight body that has access to un-blinded accumulating comparative data. The IDMC is responsible for safeguarding the interests of trial patients, monitoring the accumulating data and making recommendations to the TSC on whether the trial should continue as planned.