Clinical Trial Monitoring
This document describes the process for monitoring clinical trials.
Clinical Trial Monitoring
Monitoring is the act of overseeing the progress of a clinical trial to ensure it is conducted, recorded, and reported. This SOP applies to all clinical trials sponsored, co-sponsored or managed by King’s Health Partners (KHP) organisations.
The purpose of monitoring is to verify that:
- the rights and well-being of trial participants are protected
- reported trial data are accurate, complete, and verifiable from source documents
- the trial is conducted in compliance with the approved protocol, GCP, and applicable regulatory requirements.
Monitoring is normally carried out by King’s Health Partners Clinical Trials Office (KHP-CTO) Clinical Research Associates (CRAs) and overseen by the Quality Manager.
Externally sponsored trials hosted by a partner may also be monitored under this SOP where required. From time to time, monitoring may be contracted to external CRAs/organisations with oversight retained by the KHP-CTO.