Investigator Site Close Out Procedures

Closeout confirms that all trial activities are complete, documented, and reported. It ensures sponsor requirements are met and that essential documents are available for inspection or future reference. This Standard Operating Procedure (SOP) describes the procedures for closing out clinical trials monitored by the King’s Health Partners Clinical Trials Office (KHP-CTO).

Closeout visits are carried out by KHP-CTO Clinical Research Associates (CRAs) and overseen by the Quality Manager (or delegate). In some cases, closeout may be contracted to external organisations, but oversight remains with the KHP-CTO.

This SOP applies to all clinical trials sponsored, co-sponsored, or managed by KHP organisations. It covers both sponsor-led and site-level closeout activities.