"Clinical Trial Monitoring refers to the methods used by sponsors of investigational studies or CROs delegated responsibilities for the conduct of IND studies, to oversee the conduct of, and reporting of data from, clinical investigations, including appropriate CI supervision of study site staff and third-party contractors. Monitoring activities include communication with the CI and study site staff; review of the study site’s processes, procedures, and records; and verification of the accuracy of data submitted to the sponsor. " FDA Guidance 2013 Monitoring of clinical trials is necessary to assure that - rights and safety of patients (i.e. human subjects) are protected - reported trial data are accurate, complete, and verifiable from the source of documents - conduct of trails in compliance with the protocol, good clinical practice (GCP), and applicable regulatory requirements Clinical Trial Visit by Sponsors - Pre-study Qualification Visit - Initiation Visit - Monitoring V...