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.
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.