The Association of Clinical Research Professionals
Risk‑Based Decisions: Key Skills for Ensuring Quality Control Under ICH E6(R3) Guidance
Build confidence in making risk-based decisions that protect trial participants, support reliable trial results, and enhance trial quality.
Aligned with the latest ICH GCP E6(R3) principles, this course provides practical strategies for applying risk-based quality management (RBQM) approaches and focusing resources where they can have the greatest impact. Learn how to identify, assess, prioritize, and manage risks using Critical-to-Quality (CtQ) factors, while incorporating Quality by Design (QbD) principles into trial planning and conduct. Topics include risk identification and assessment, risk prioritization, risk response selection, mitigation planning, evaluation of mitigation effectiveness, communication and collaboration, and continual improvement.
At the end of this course, participants should be able to:
Explain the importance of risk-based decision-making and its role in protecting trial participants and supporting reliable trial results.
Describe how ICH GCP E6(R3) supports risk-based quality management and risk-proportionate approaches throughout the trial lifecycle.
Apply a structured process to identify, assess, prioritize, and manage risks affecting trial participant safety and reliable trial results.
Differentiate among risk response strategies, including risk avoidance, mitigation, and acceptance.
Explain how ongoing evaluation supports risk-based decision-making throughout the trial lifecycle.