Navigating the FDA’s Draft Guidance on Protocol Deviations: What You Need to Know and Why It Matters
“Deviation” Doesn’t Have to Be a Dirty Word If you’ve worked in clinical research for any amount of time, you’ve likely encountered a protocol deviation—or ten. A missed visit here, a delayed lab draw there—it’s a reality of running clinical trials. But not all deviations are created equal, and that’s exactly why the […]