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中文摘要: 2019年12月1日起临床试验机构全面施行备案制管理，对机构办公室的工作提出了更高的要求。机构办公室借鉴ISO9001-2015标准进行质量管理体系的建设，通过质量管理体系的建立、有效实施，过程的持续改进和预防不合格，增强持续提供满足试验及适用法律法规要求的能力。
中文关键词: 临床试验机构 备案制 ISO9001-2015标准 质量管理体系
Abstract:It has experienced more than 30 years of development for China’s clinical trial institutions，and the office of clinical trial institutions plays an important role in the implementation of clinical trials. Since December 1，2019，the clinical trial institutions has been full implemented to filing system，which puts higher requirements on the work of institutional offices. The office of the institution builds the quality management system according with the ISO9001-2015 standard，which can help the continuous improvement of the process and the prevention of non-conformance，enhance the ability to continuously meet the requirements of the clinical trials and applicable laws and regulations.
keywords: clinical trial institution office filing system ISO9001-2015 standard quality management system
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基金项目:“重大新药创制”科技重大专项（2017ZX 09304022） “重大新药创制”科技重大专项（2017ZX 09304022）
引用文本：
杜艾桦*.基于ISO9001-2015的临床试验机构质量管理体系的建设△[J].江苏卫生事业管理,2020,31(4):415-418.
Du Aihua*.Research on the Office Quality Management System of the Clinical Trial Facility based on the ISO9001-2015△[J].Jiangsu Health System Management,2020,31(4):415-418.
杜艾桦*.基于ISO9001-2015的临床试验机构质量管理体系的建设△[J].江苏卫生事业管理,2020,31(4):415-418.
Du Aihua*.Research on the Office Quality Management System of the Clinical Trial Facility based on the ISO9001-2015△[J].Jiangsu Health System Management,2020,31(4):415-418.
