Monitoring Clinical Trials

This course provides a thorough grounding in the principles and practices of clinical trial monitoring, focusing on the critical role of the monitor in safeguarding participant rights, well-being, and the integrity of trial data. Participants will learn to conduct effective site initiation, routine monitoring, and close-out visits, with an emphasis on verifying protocol adherence, ensuring accurate data collection against source documents, and managing regulatory compliance in line with ICH-GCP guidelines. Through practical scenarios, you will develop the skills to identify and resolve issues proactively, effectively communicate with investigative sites, and ensure that trials are conducted, recorded, and reported in a compliant and audit-ready manner.