ICH—GCP 適用臨床試験に必要な効率化された施設訪問モニタリング支援体制の構築

Considering the high cost required for monitoring including source document verification（SDV）to ensure the quality of industry‒sponsored clinical trials, it is important to establish a monitoring system for investigator‒initiated trials that can conduct efficient monitoring with limited resources. In April 2013, National Hospital Organization（NHO）Nagoya Medical Center was selected as a hospital of the project for clinical research core hospital and we developed a monitoring support system utilizing the NHO network. From the seven NHO hospitals, monitor candidates were selected according to the acquisition of an advanced CRC certification and a GCP passport of the Japan Society of Clinical Trials and Research. After the monitor candidates received initial and continuous training, they were assigned to GCP‒compliant clinical trials. The NHO monitoring system has supported one ICH‒GCP‒compliant international collaborative trial and eleven J‒GCP‒compliant trials. During this activities, we have developed a check sheet for skill management for monitor and project leader. Several IT systems were also developed to improve information sharing required for monitoring. Utilizing the NHO network, we have developed an effective monitoring support system.