Clinical trial management: Monitoring progress, sites and safety; New paradigms for efficiency.

There has been a recent focus on providing adequate clinical oversight in a shrinking economic support environment. Concepts of remote monitoring to descrease travel costs and time, on-site monitoring that is structure to review specific information and developed with a frequency based on the risk level of the intervention, and streamlined safety reporting all combine to allow comprehensive clinical trial oversight. The use of robust web-based data systems allows for daily updates of clinical trial progress, automated notification of specific events, data quality checks at the time of data entry, built-in logic checks, remote monitoring capabilities, and real-time review of safety events.

The NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) experience serves as a model to transition to real-time reporting of trial progress, to risk-based clinical site monitoring and strategic risk-based safety reporting. A comprehensive clinical trial progress assessment has been created with site and safety monitoring plans that can improve the efficiency of monitoring programs. This poster describes examples and tools from the CTN that offer alternatives to standard clinical trial oversight and to 100% data auditing while maintaining data and ultimately study integrity.