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[德国临床试验注册:原因、一般及技术层面、国际整合]

[The German Clinical Trials Register: reasons, general and technical aspects, international integration].

作者信息

Dreier G, Hasselblatt H, Antes G, Schumacher M

机构信息

Zentrum Klinische Studien, Universitätsklinikum Freiburg, Elsässer Strasse 2, 79110, Freiburg.

出版信息

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2009 Apr;52(4):463-8. doi: 10.1007/s00103-009-0833-5.

Abstract

In order to provide a central portal for information on clinical research in Germany and thus to facilitate the search of planned, ongoing and completed clinical trials, the German Clinical Trials Register (GermanCTR) was implemented in cooperation with the WHO's registries network. It is an open access online register of clinical trials conducted in Germany, which allows all users to search for, register and share information on clinical trials. The project is funded by the Federal Ministry of Education and Research and is implemented at the Institute for Medical Biometry and Medical Informatics of the University Medical Center Freiburg as a joint project of the Clinical Trials Center Freiburg and the German Cochrane Center. Since October 2008 the GermanCTR is an approved WHO Primary Registry and allows clinical trial registration in Germany according to the requirements of the International Committee of Medical Journal Editors (ICMJE). Reasons for a national trials register, general and technical aspects of implementing the GermanCTR as well as the national and international integration are described here.

摘要

为提供一个关于德国临床研究信息的中央门户,从而便于搜索已规划、正在进行和已完成的临床试验,德国临床试验注册中心(GermanCTR)与世界卫生组织的注册机构网络合作实施。它是一个在德国进行的临床试验的开放获取在线注册库,允许所有用户搜索、注册和共享临床试验信息。该项目由联邦教育与研究部资助,在弗莱堡大学医学中心的医学计量与医学信息研究所实施,是弗莱堡临床试验中心和德国考科蓝中心的联合项目。自2008年10月起,GermanCTR成为世界卫生组织认可的一级注册机构,并允许按照国际医学期刊编辑委员会(ICMJE)的要求在德国进行临床试验注册。本文介绍了设立国家试验注册中心的原因、实施GermanCTR的一般和技术方面以及国内和国际整合情况。

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