Guided Notes
Risk-Based Quality Management
Quality by design, critical-to-quality factors, risk assessment, key risk indicators (KRIs), quality tolerance limits (QTLs), central statistical monitoring and CDM's role.
Quality by design
Slide 1 / 5ICH E6(R3) and E8(R1) ask sponsors to build quality in from the start: • Identify critical-to-quality (CtQ) factors — the data and processes that matter most for participant safety and reliable results (e.g. eligibility, consent, primary endpoint measurement, SAE reporting, dosing). • Focus effort there instead of checking everything equally. • Design simpler protocols and CRFs that avoid unnecessary data.