International Council for Harmonisation (ICH) E6 2025 – 400 Free Practice Questions to Pass the Exam

The trial monitor plays a crucial role in ensuring the integrity of the data collected during a clinical trial and adherence to the study protocol. This responsibility is pivotal for maintaining the quality and credibility of the trial results. The monitor conducts regular site visits, reviews study documentation, and verifies that the trial is being carried out in compliance with regulatory requirements and the protocol specifications. This oversight helps to ensure that any deviations or issues are identified and addressed promptly, ultimately protecting the rights and safety of participants as well as the scientific validity of the study outcomes.

While participant recruitment, communication between the sponsor and investigators, and financial management are important aspects of running a clinical trial, they are not the primary responsibilities of the trial monitor. The monitor’s focus is predominantly on data integrity and protocol adherence, which are foundational elements for the overall success and reliability of clinical trial results.