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

Prepare for the International Council for Harmonisation (ICH) E6 Exam. Engage with multiple choice questions, hints, and explanations to boost your knowledge. Ace your ICH E6 test!

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.

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