The monitoring process is designed to ensure that the clinical trial is conducted in compliance with the human health and rights, study protocol, principles of Good Clinical Practice (GCP), and with the applicable regulatory requirement(s) . Compliance with GCP provides public assurance that the rights, safety and well-being of trial subjects are protected, and all the data were recorded, analyzed and accurately reported in source documents. The frequency and other aspects of monitoring visits are detailed in the Clinical Monitoring Plan (CMP). During the course of the study, one or more monitors are responsible for monitoring the progress of the study in each center. These visits can be done physically or remotely.
