A Close-Out Visit (COV) is a monitoring visit conducted when a clinical research site has completed its participation in a clinical trial. The visit helps confirm that required study activities have been completed, outstanding issues have been addressed, and study records and materials are appropriately finalized before the site is formally closed.
During a COV, a clinical research associate (CRA) or other sponsor or contract research organization (CRO) representative may review essential and regulatory documents, resolve outstanding data queries, verify investigational product accountability and disposition, confirm safety reporting requirements have been met, and review requirements for retaining study records. The monitor may also discuss ongoing investigator responsibilities, including record retention and responding to future sponsor or regulatory requests.
An effective close-out visit helps ensure the site’s study documentation is complete and accurate and that remaining responsibilities are clearly understood. COVs support appropriate study closure, regulatory compliance, data integrity, and the maintenance of essential clinical trial records.