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Question: The overall goal of monitoring, audits, and inspection activities is to:
Quick answer: Ensure the protection of human research subjects and data integrity.
This question is a part of GCP Audits And Inspections Of Clinical Trials Of Drugs And Biologics.
The overall goal of monitoring, audits, and inspections in clinical research is to ensure the protection of human research subjects and the integrity of the data collected.
Monitoring activities involve regular oversight of the conduct and progress of a clinical trial to verify that it is being carried out as planned, that participants’ rights and well-being are protected, and that data are accurately and reliably recorded and reported.
Audits are independent examinations of trial-related activities and documents. They determine whether the evaluated trials are conducted and data are recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements.
Inspections are conducted by regulatory authorities (like the FDA, EMA, etc.) to verify that a clinical trial is conducted according to the protocol, GCP, and regulatory requirements, to ensure the protection of the rights, safety, and welfare of human subjects, and the reliability and integrity of collected data.
These activities are crucial components of a robust system for safeguarding the rights and well-being of clinical trial participants and ensuring the integrity and validity of the data collected in these studies.
For further reading on this topic, consider the International Council for Harmonisation’s Guideline for Good Clinical Practice (ICH E6), which provides extensive information on the principles and practices of monitoring, audits, and inspections in clinical research (link).
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