Monitoring is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, SOPs, GCP and applicable regulatory requirements. The clinical research monitor is the person with direct access to, and oversight of the site research activities. They conduct monitoring visits in accordance with a monitoring plan and provide feedback and training to sites as necessary.
Regular site monitor visits can be broken down into four types: pre-study visits, initiation visits, periodic monitoring visits, and close-out visits. Study sites may also be monitored or audited by the FDA, Clinical Research Organizations (CROs), IRBs and sponsors.
Before the study begins the monitor may come out for some pre study visits, or those may be conducted remotely. A site initiation visit will be conducted, in person or remotely, to formally document that a site is ready to begin engaging in the conduct of the trial.
At the start of the study the monitor should be identified, the site should be qualified by the OCR Regulatory Services team. For industry sponsored trial, a monitor will be provided. For IITs it would be necessary to identify a monitor for the study.
The monitor is typically part of the Site Initiation Visit (SiV), led by the Regulatory Sponsor for the study. The monitor will then conduct ongoing monitoring, according to the data safety monitoring plan, throughout the trial.