@article{oai:repo.qst.go.jp:00079835,
 author = {栗原, 千絵子 and Kurihara, Chieko},
 issue = {1},
 journal = {臨床評価},
 month = {Apr},
 note = {Background：The Clinical Trials Act came into force in April 2018, and it requires conduct of clinical trials of medicinal product at a higher level of control than clinical trials regulated by the Governmental Ethical Guidelines. However, this level does not reach the level of Good Clinical Practice (GCP), an international standard for clinical trials applied in Japan to the trials aiming at new drug applications. In addition, discussions and information sharing among stakeholders engaged in the operation of the Act are insufficient
from the perspective of protecting research subjects and assuring the quality of the trials.
Objectives：This study aims to clarify the challenges in implementation of the Act and make proposals for improvement.
Method：This study uses a comparative analysis of the three regulations for clinical trials in Japan and a discussion based on the authors’ practical experience. This first report focuses on the quality and safety
assurance of medicinal products.
Results, Discussions, and Conclusions：We should conduct clinical trial under the Act, recognizing that the regulations under the Act define a policy of “Protection of subjects and quality assurance of the study,” which is compatible with the GCP standard. Additionally, we need to improve the operation of the Act in terms of investigational brochures, non-clinical studies, manufacturing standards, and adverse event reporting to move closer to the level to GCP for the purposes of quality and safety assurance for investigational medicinal products. This should be done at the level of the management system for the
research team and research institution. We will provide our additional analysis of quality control and assurance of the study and for research subject protection in the second and the third reports.},
 pages = {127--152},
 title = {臨床研究法の現状における課題と運用改善に向けた提言：GCP・医学系指針及び海外制度との比較から－第1報　医薬品等の品質・安全性の確保－},
 volume = {47},
 year = {2020}
}