Clinical Trial Monitoring

Monitoring is defined as the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, The Principles of GCP, and the Medicines for Human Use (Clinical Trails) Regulations - where applicable.

The purpose of monitoring is to verify that:

  1. The rights and well-being of the human subjects are protected

  2. The reported trial data are accurate, complete and verifiable from source documents

  3. The conduct of the trial is in compliance with the currently approved protocol/amendment(s), GCP and the applicable regulatory requirements.

Monitoring is an integral role in the quality control of a clinical trial and is designed to verify the ongoing quality of the study. All clinical trials sponsored or co-sponsored by one or more of the Partner Organisations will be monitored as described in this SOP. Trials sponsored by organisations other than the Partner Organisations may also be monitored according to this SOP from time to time.

Monitoring will be conducted by the KHP CTO CRAs and overseen by the Quality Manager. From time to time, monitoring may be contracted out to external organisations/CRAs, but oversight retained by the KHPCTO.

SOP: Clinical Trial Monitoring (7.1MB) 

Related Documents

Monitoring Visit Report Form template (.doc 1MB)

Contact Comment Form template (.doc 1.2 MB)

Note to File template (.doc 900KB)

Monitoring Plan (.pdf 250Kb)