The U.S. Food and Drug Administration (FDA) has issued draft guidance intended to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting. Titled “Oversight of Clinical Investigations— A Risk-Based Approach to Monitoring,” the guidance (i) “assists sponsors in developing risk-based monitoring strategies and plans for clinical investigations of human drugs, biologics, medical devices, and combinations thereof”; and (ii) “clarifies that sponsors can use a variety of approaches to meet their responsibilities for monitoring investigational new drug or investigational device exemption studies.” See Federal Register, August 7, 2013.