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 webinar introduced the foundational principles of project management in the clinical research environment, with a focus on how these skills show up in day-to-day study operations. Panelists explored key concepts such as scope, timelines, communication, risk, stakeholder alignment, and change management.
This webinar explored how policy decisions and regulatory priorities influence clinical trial operations, site workflows, technology adoption, and participant access. Through a discussion of both the broader policy landscape and real-world operational impact, clinical research professionals can better understand policy shifts, anticipate downstream effects, and engage more thoughtfully in conversations that shape the future of clinical trials.
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.