What type of monitoring is referred to as “Centralized Monitoring”?

What type of monitoring is referred to as “Centralized Monitoring”?

• A. A remote evaluation of data accumulation
• B. A physical site inspection by an auditor
• C. An in-person review of all trial subjects
• D. A monthly report to the FDA

Answer: (A)

Centralized Monitoring refers to a remote evaluation of data accumulation, which is designed to assess various aspects of a clinical trial from a centralized location, often using technology and data analytics. This approach allows for the examination of data collected at multiple sites without the need to physically visit each site. Centralized Monitoring enables sponsors and clinical research organizations to identify patterns, trends, and inconsistencies in the data, ensuring that the trial is being conducted in compliance with regulatory requirements and that data integrity is maintained. By doing so, it can enhance efficiency by focusing resources on sites or data that may require closer scrutiny while allowing for real-time data oversight. The other choices describe methods of monitoring that involve physical presence or direct reporting, which do not align with the concept of Centralized Monitoring. It emphasizes the use of remote techniques rather than on-site evaluations, distinguishing it as an innovative approach in the field of clinical trials.

Centralized Monitoring refers to a remote evaluation of data accumulation, which is designed to assess various aspects of a clinical trial from a centralized location, often using technology and data analytics. This approach allows for the examination of data collected at multiple sites without the need to physically visit each site.

Centralized Monitoring enables sponsors and clinical research organizations to identify patterns, trends, and inconsistencies in the data, ensuring that the trial is being conducted in compliance with regulatory requirements and that data integrity is maintained. By doing so, it can enhance efficiency by focusing resources on sites or data that may require closer scrutiny while allowing for real-time data oversight.

The other choices describe methods of monitoring that involve physical presence or direct reporting, which do not align with the concept of Centralized Monitoring. It emphasizes the use of remote techniques rather than on-site evaluations, distinguishing it as an innovative approach in the field of clinical trials.