UNIT 10: Monitoring, Quality Management, and Inspection Readiness
This unit explains how clinical trials are monitored and controlled to ensure subject protection, data reliability, and regulatory compliance throughout the study lifecycle. It also covers quality systems, audits, inspections, and documentation practices required to demonstrate inspection readiness.
Clinical trial monitoring is performed to verify that the rights and well-being of subjects are protected, that reported trial data are accurate and verifiable from source documents, and that the trial is conducted in compliance with the protocol, GCP, and applicable regulations. Monitoring provides continuous oversight and early identification of issues that could affect subject safety or data integrity.
Key Points
Protects subject rights and safety
Ensures data accuracy and completeness
Confirms protocol and GCP compliance
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