A Challenge for Quality Assurance of Investigator-Initiated Clinical Trials at Osaka University Hospital

[Speaker] Yukiko Shiromoto:1
[Co-author] Yoichi Yamamoto:1
1:Medical Innovation, Osaka University Hospital, Japan

Clinical Research Act was promulgated in April 2017, in order to improve the reliability of clinical research. It focuses on (1) assuring the quality of clinical research, (2) protecting research subjects, (3) securing transparency in the provision of funds and labor provided by pharmaceutical companies. The environment surrounding clinical research is changing drastically.
Protection of the safety and welfare of the subjects must be prioritized over the scientific and social outcomes of clinical research. At Osaka University Hospital, we keep that in mind, and are doing various initiatives to achieve the three items above.
One of them is a new audit approach called 'educational audit' requested by the institutional review board to maintain and improve the reliability of clinical research.
This audit is performed in the early stage of the research to enable the investigators to take corrective and preventive actions as well as facilitate the implementation of the research. All investigator-initiated interventional research except Japanese GCP based clinical trials at Osaka University Hospital are the subjects for this educational audit. Our challenges and issues need to be addressed will be presented.
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