Creation and Maintenance of Trial Master File

Monitoring is the act of overseeing the progress of a clinical trial to ensure it is conducted, recorded, and reported. 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 usually carried out by King’s Health Partners Clinical Trials Office (KHP-CTO) Clinical Research Associates (CRAs) and overseen by the Quality Manager.

This Standard Operating Procedure (SOP) describes the process of monitoring clinical trials. It applies to all clinical trials sponsored, co-sponsored or managed by King’s Health Partners (KHP) organisations.

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.