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Queen's University
BelfastResearch and EnterpriseStandard Operating Procedure
Research Governance
Title:Monitoring of Clinical Trials of Investigational Medicinal
Products SOP Reference Number:QUBADRE023Date
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What is monitoring of clinical trials?
Monitoring of clinical trials is the process of overseeing and checking the conduct of a clinical trial to ensure that it is conducted in accordance with the protocol and regulatory requirements.
Who is required to file monitoring of clinical trials?
The sponsor or investigator of a clinical trial is required to file monitoring reports.
How to fill out monitoring of clinical trials?
Monitoring reports are typically filled out by the monitor or clinical research associate who is overseeing the trial.
What is the purpose of monitoring of clinical trials?
The purpose of monitoring of clinical trials is to ensure the safety of participants, the reliability and integrity of the data, and compliance with regulations.
What information must be reported on monitoring of clinical trials?
Monitoring reports typically include information on site visits, protocol deviations, adverse events, and data discrepancies.
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