A Real-World ICH E6 R3 Implementation Example

Joe Fitzgerald, head of clinical data processing and reporting at Regeneron, provides a concrete example of operationalizing ICH E6 R3's risk proportionate principles using a Phase 3 oncology trial. He walks through the complete framework: Critical to Quality (CT scans within ±7 days), Key Risk Indicators (percentage of late scans), Quality Tolerance Limits (less than 10% cumulative late), and planned responses — making abstract concepts tangible and actionable.