Tips and Tricks for Effective Clinical Monitoring and Safety Oversight

Effective monitoring is an integral part of Good Clinical Practice (GCP) and fundamental for the success of global clinical trials. Monitors must ensure that procedures are consistent and safe for each participant throughout the trial; apply stringent checks on data collection to provide high quality data and credible results; and help the trial reach its objectives within the specified time frames. No trial is too small to implement good monitoring practices. A clear and comprehensive monitoring plan is essential to the work of CRAs. This lecture provides tips and tricks for understanding the impact of key points, such as the amount of on-site and central monitoring activities; the policies for review and collection of source documents; and the tasks and interactions of the data management team and other oversight committees such as DSMB/CEC. Participants will also explore simple tools for monitoring visit forecasting and CRA management in multisite-multinational clinical trials.