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日本初级注册网络的背景、介绍和活动。

Background, introduction and activity of the Japan Primary Registries Network.

机构信息

Office of Clinical Trial Promotion, Research and Development Division, Health Policy Bureau, Ministry of Health, Labour and Welfare, Japan.

出版信息

J Evid Based Med. 2009 Feb;2(1):41-3. doi: 10.1111/j.1756-5391.2009.01013.x.

Abstract

Regarding registration and publication of clinical trials, there are now three registry organizations in Japan; the University Hospital Medical Information Network (UMIN), the Japan Pharmaceutical Information Center (JAPIC) and the Japan Medical Association - Center for Clinical Trials (JMACCT). In addition, a portal site which supports searching for information on clinical trials in all three registries has been operated by the National Institute of Public Health (NIPH). After we established a cooperative system, we became a WHO Primary Registry on October 16, 2008 and announced this in Japan on the next day. This cooperation system is called the Japan Primary Registries Network (JPRN). In order to show that this type of network works well as a Primary Registry, we are cooperating with global activities of World Health Organization's International Clinical Trial Registry Platform (WHO ICTRP) to promote clinical trials and propose appropriate idea to the world.

摘要

关于临床试验的注册和发表,目前日本有三个注册机构,即大学医院医疗信息网络(UMIN)、日本制药信息中心(JAPIC)和日本医师协会-临床试验中心(JMACCT)。此外,国立公共卫生研究所(NIPH)还运营了一个支持在这三个注册机构中搜索临床试验信息的门户网站。在建立合作系统之后,我们于 2008 年 10 月 16 日成为世界卫生组织一级注册机构,并于次日在日本宣布了这一消息。这个合作系统被称为日本一级注册机构网络(JPRN)。为了展示这种网络作为一级注册机构的良好运作,我们正在与世界卫生组织国际临床试验注册平台(WHO ICTRP)的全球活动合作,以促进临床试验并向世界提出恰当的建议。

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