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 course equips clinical research professionals with practical strategies to evaluate recruitment pathways, identify barriers to participation, and implement thoughtful improvements grounded in ICH E6(R3) principles.
Learn the essentials of clinical trials and the global standards that govern them. This 90-minute online course provides a clear, structured introduction to the process, roles, and guidelines that ensure ethical and effective research.