Developing a monitoring plan that outlines the approach to quality assurance is essential for maintaining data integrity throughout the clinical trial. This plan helps identify critical data points, risk-based monitoring strategies, and procedures for detecting and correcting data discrepancies. It ensures that the study data collected is accurate, complete, and verifiable.
GCP guidelines emphasize the importance of a monitoring plan to safeguard the quality and integrity of study data.
"The sponsor should develop a comprehensive monitoring plan to ensure the accuracy, completeness, and consistency of trial data."
Objectives:
Maintain high-quality data through structured monitoring.
Identify potential risks and address them proactively.
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