[Associations with Clinical Trials].

Since the necessity of confirming records to ensure appropriate accuracy management for clinical laborato- ry tests was initially specified in the Good Clinical Practice (GCP) in 2011, it has been mandatory for clinical trial sponsors to confirm such management in the relevant medical institutions. In 2007, the Department of Clinical Laboratory and the Department of Blood Transfusion at Okayama Uni- versity Hospital acquired the ISO 15189 certification as the international standard for clinical laboratory tests. In 2015, they, including the Physiological Test Room, renewed this certification. Record documents to ensure appropriate accuracy management are stored in the Department of Clinical Laboratory for a fixed period. Subsequently, to be inspected by regulatory authorities, such as the PMDA, they are continuously stored in the Department of Clinical Research of New Drugs and Therapeutics for a long period. [Review].