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.
This course answers the fundamental question, “What is clinical trial monitoring?” while providing a practical introduction to the monitor’s role, responsibilities, and activities throughout a clinical trial. Explore on-site, remote, centralized, and risk-based monitoring approaches aligned with ICH GCP E6(R3).
This course provides a practical framework for assessing trial feasibility and selecting trials that align with your site’s capabilities, patient population, and strategic goals. Applying ICH GCP E6(R3) principles to site-level feasibility decisions, you will learn how to use historical trial performance data, current patient population data, and the four key feasibility elements, interest, accruability, capacity, and trial portfolio alignment, to evaluate protocols, identify potential risks, support participant-focused trial conduct, and make informed, defensible trial selection decisions.
This 90-minute course explores investigator responsibilities through the lens of ICH E6(R3), with supporting references to applicable FDA regulations and related ICH guidance. Through practical examples and real-world scenarios, you’ll examine expectations for investigator oversight, accountability for delegated activities, and the responsibilities that remain with investigators throughout the trial lifecycle.
This course equips clinical research professionals with practical strategies for preparing for, managing, and responding to regulatory inspections with confidence. Applying ICH GCP E6(R3) principles, learners will explore risk-based quality management, oversight, essential records, data integrity, and quality system practices that support continuous inspection readiness throughout the clinical trial lifecycle.