摘要
随着临床试验国际化进程的加快,在中国进行的国际合作临床试验逐渐增多。保证临床试验的科学性和维护受试者的权益,需要伦理委员会的审查和监督管理。介绍日本伦理委员会审查研究规程的视点,旨在使我国广大临床工作者了解国外的伦理审查工作,以期对提高国内的临床试验水平和质量控制提供参考。
With the acceleration process of the internationalization of clinical trials, global multi - center clinical trials gradually increased in China, which requires ethics review and supervision to ensure the scientific nature, the implementation of patient's rights and interests of clinical trials. This paper introduced the review points on the study protocols in Japanese ethics committee, aiming at improving the domestic clinical trials level and quality controls by summarizing the foreign experiences.
出处
《中国医学伦理学》
2011年第5期670-672,共3页
Chinese Medical Ethics