FDA regulations require that clinical trial sponsors monitor the progress of their trials, but do not specify how monitoring must be conducted. The speaker will discuss FDA’s 2011 draft Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring and its recommendations, which when finalized will represent FDA’s current thinking on appropriate monitoring. The session will highlight how central statistical monitoring can support data reliability and provide effective oversight. Examples will be given of how statistical and other central monitoring methods could have been used to detect issues identified upon inspection. The speaker will also discuss ongoing CDER pilots with industry to facilitate adoption of risk-based approaches to monitoring. Finally, the speaker will explore how monitoring fits into the larger context of approaches to building quality into trial design and implementation (“Quality by Design”).