用于GCP审计的JSQA指南

Quality Assurance Journal Pub Date : 2007-03-01 DOI:10.1002/QAJ.403

Hiroshi Shimokai, Seiichi Hata, T. Tamura, Yoshiaki Yano, Shuhei Abe, Masayuki Takezawa, M. Yogo, T. Kajiho, Kuniko Gotou, Akio Izawa, Muneyoshi Ookawa, Hiroyasu Yamashita, Fumiko Alaya, Yukiko Shiromoto, Kiyoshi Takahashi

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引用次数: 0

摘要

国际协调会议(ICH)良好临床规范(GCP)已被美国、欧洲和日本三个地区采用，并于1996年实施。GCP审核的细节在ICH GCP中没有提供。日本质量保证协会(JSQA)编制了《JSQA GCP审核指南》，以推动全球对GCP审核的讨论，并期望与ICH GCP一起建立全球GCP审核指南。该指南将包括发起人审计部门的任务和组织，并建立计划、执行和报告审计的原则。该指南预计将成为ICH GCP的基本原则，不仅适用于主办方的审核员，也适用于独立审核员和合同研究组织(cro)的审核员，以便在每个国家和主办方的各种情况下进行审核。版权所有©2007 John Wiley & Sons, Ltd

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The JSQA guideline for GCP auditing

The International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) has been adopted by three regions USA, Europe and Japan and implemented since 1996. Details of GCP auditing are not provided in ICH GCP. The Japan Society of Quality Assurance (JSQA) has prepared ‘The JSQA GCP Guideline for GCP Auditing’ to promote the global discussion on GCP auditing and expects to establish a global guideline on GCP auditing along with ICH GCP. The guideline will include the mission and the organization of a sponsor's auditing department and establish the principles for planning, performing, and reporting audits. The guideline is expected to be a basic principle along with ICH GCP for not only sponsor's auditors, but also independent auditors and auditors of Contract Research Organizations (CROs) to conduct an audit in the various situations of each country and sponsor. Copyright © 2007 John Wiley & Sons, Ltd.

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Quality Assurance Journal

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