Current Edition

Risk-based Monitoring: The New Regulatory Landscape, and Conjectures on the Future of Clinical Trial Execution

In early August 2011 the European Medicines Agency released a draft document entitled Reflection Paper on Risk Based Quality Management in Clinical Trials. Later the same month the US Food and Drug Administration released a draft Guidance for Industry entitled Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring. In this paper Amanda Sax, Margaret Keegan, Dan White, and Rick Turner at Quintiles will focus on the draft document from the FDA, and offer conjectures on the implications of the new regulatory landscape it engenders, assuming that the final document remains similar in spirit to that of the current drafts.