Clinical Trial Monitoring

The purpose of this SOP is to describe monitoring procedures for clinical trials monitored by the KHP CTO in order that Clinical Trials conducted within the partner institutions comply with UK and European Law. These laws comprise; Statutory Instrument 2004/1031 – the Medicines for Human Use (Clinical Trials) Regulations 2004 which transposed the European Union Directive 2001/20/EC for Clinical Trials into UK law effective from the 1st May 2004. The original UK regulations were amended in August 2006 to incorporate the EU Good Clinical Practice Directive (2005/28/EC) as Statutory Instrument 2006/1928.

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, GCP, and the applicable regulatory requirement(s).

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 as required, monitoring may be contracted out to external organisations/CRAs, but oversight retained by the KHP CTO.

SOP: Clinical Trial Monitoring (1.7MB) 

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