Monitoring of a Clinical Trial Site
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.
