This course introduces ICH E6(R3) principles and helps build confidence in managing Essential Records using ALCOA-C+–aligned record management practices. Explore how well-managed records support data integrity, effective Trial Master File (TMF) practices, inspection readiness, and risk-based quality management throughout the trial lifecycle.
This 90-minute, self-paced course introduces core concepts from ICH E9 and ICH E9(R1) and explores how these principles are applied in practice through the risk-based, quality-focused approach emphasized in ICH E6(R3). Designed for non-statisticians, the course focuses on practical understanding rather than mathematical detail.
This 90-minute course introduces the drug development process through the lens of ICH E8(R1) and ICH E6(R3), helping you understand how development plans, trial objectives, and quality-focused decision-making align across the clinical development lifecycle. You’ll explore how risk-proportionate, quality-by-design approaches—and Critical-to-Quality (CtQ) thinking—support participant safety, reliable results, and operational feasibility in real-world clinical research.
This self‑paced course introduces the core concepts, models, and terminology associated with DCTs, with a strong emphasis on the principles outlined in ICH E6(R3).
This course introduces the essential components of a modern, risk-based Quality Management System (QMS) and reflects the updated expectations outlined in ICH E6(R3).