study manager, on-site monitors/CRAs) and tracking of risk/issue(s) until resolution Facilitating early identification of risk/issue(s) occurring during study conduct and responsible for identification risk alerts, timely escalation of risk/issue(s) to relevant stakeholders ( e.g.Monitoring of risk reports, data trending related to quality, safety, efficacy (effectiveness), site performances, budget etc., generated by analytical and visualization or risk management tool.Ongoing/periodic monitoring of patient data, site data centrally using appropriate technology for single or multiple studies to ensure high data quality and patient safety.However, considering the scope of centralized monitoring and RBM processes, the following could be the key responsibilities of the central monitor that one can consider to make justice to this role. At the same time, as the process is still evolving, it will take some time to fine-tune responsibilities or job description of the central monitor in the market. Therefore, considering overall objectives of centralized monitoring, the central monitor plays a vital role in this process and is a key driver to facilitate the process. As the central monitor would be checking the study data and risk reports on real-time basis using appropriate technology to monitor data quality, patient safety and relevant risks, he/she would be the first person to detect any study related risk/issue(s). With the introduction centralized monitoring in a risk-based monitoring (RBM) approach, the central monitor is emerging as a key and important role in successful implementation of this new monitoring approach. In fact, the regulators encourage use of centralized monitoring techniques wherever appropriate. With the advent of various eClinical technologies, analytical and visualization tools, it is easy to check the data and reports centrally or remotely.

Centralized monitoring offers many of the capabilities of on-site monitoring as well as additional capabilities.

Center monitor