FDA has recently issued two important and related draft guidance documents covering electronic source and risk-based monitoring. FDA now clearly expects sponsors to take better advantage of electronic data capture (EDC) technology by implementing a targeted, risk-based approach to monitoring data remotely. Targeted source document verification (SDV) can be a highly effective and low-cost method of implementing an innovative monitoring strategy where 100% monitoring of site data is costly and not needed. Yet, in light of these potential cost savings, targeted SDV is still more of a frequent discussion topic rather than a reality. This symposium will provide perspectives on how this guidance could change the day-to-day relationships of sites/sponsors/monitors.

Learning Objectives:
Discuss FDA's Draft Guidance documents on electronic source and risk-based monitoring
Identify the issues decision makers must consider when implementing targeted source document verification (SDV), including the factors needed to calculate a detailed return on investment (ROI)
Recognize the operational impact of risk-based monitoring on sites/sponsors/monitors.