From the Perspective of the Clinical Research Center

Abstract

The Clinical Trials Act requires a lot of paper-work including on conflicts of interests and sets deadlines for submitting reports regarding unexpected adverse events etc. Due to the heavy responsibilities of investigators, the number of clinical trials has been dramatically decreasing. The clinical research center could play an important role in improving this situation. In the academic clinical research center at Osaka University Hospital, a brush-up meeting is carried out and application documents are examined before submission to the certified review board. If necessary, the meeting assists investigators in writing protocol in compliance with regulations. In addition, the meeting serves as a help desk for consultations, making protocols, and establishing research infrastructure. To promote clinical trials, the involvement of the clinical research center is essential.