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). Examine the purpose and typical activities of site selection, site initiation, interim or routine monitoring, and close-out visits. Along the way, consider how monitors review trial conduct, communicate findings, and follow up on issues involving participant protection, protocol compliance, trial data, investigational product, and essential records. Designed for clinical research professionals seeking foundational knowledge of monitoring, this course explains how monitoring contributes to appropriate trial conduct and quality throughout the clinical trial lifecycle.
At the end of this course, participants should be able to:
Approved for 1.5 ACRP Contact Hours | Available 1 Year from Enrollment Date