This module introduces the fundamental principles and practices involved in monitoring clinical trial sites. It covers definitions and types of clinical trials, the application of Good Clinical Practices, and the roles and responsibilities of sponsors, investigators, and institutional review boards. Learners will review essential documentation processes and quality functions such as data capture, quality control, and assurance. The module also explains the purpose and scope of trial monitoring, including the qualifications and responsibilities of monitors, data standards like ALCOA + CCEA, and the different types of monitoring activities.
In addition, it outlines key monitoring plans and reports, the stages of site visits, from qualification and initiation to interim and close-out, and concludes with an overview of remote and risk-based monitoring. Learners will understand the role of remote monitors, their training needs, and oversight responsibilities, as well as how to apply assessment and implementation plans for effective trial management. By the end of the module, participants will have a clear understanding of how to ensure data integrity, compliance, and consistent quality throughout the clinical trial process. This module is intended for all research personnel, and particularly useful for clinical research coordinator professional development.
Approximate Duration: 4 Hours
