Monitoring substudy

Quality management of clinical trials usually includes on-site monitoring as a substantial component of the process to ensure the protection of study participants and the reliability of study results. Though on-site monitoring does provide opportunities for training and interaction with study personnel, it is expensive, time consuming and questions have been raised about its effectiveness at identifying important problems at study sites. Monitoring can be done on different levels: 1) central: sponsor reviewing and responding to reported data on submitted Case Report Forms (CRF), 2) local: clinical sites review medical and regulatory charts for unreported data, and 3) on-site monitoring: CHIP monitors visit the clinical site.

The START study presents an opportunity to compare two different monitoring practices: 1) central and local vs. 2) central and local monitoring, plus on-site monitoring. The two monitoring practices differ from one another in both intensity and cost. With over 200 clinical sites participating in START, participating clinics have been randomize to one of the two monitoring practices, and to investigate differences in measures of study quality.

The purpose of this substudy is to determine whether the addition of one annual on-site monitoring by CHIP (or its monitor collaborators in Germany and Spain) to central monitoring by the sponsor and local monitoring is superior to central and local monitoring alone.