| 临床试验通用稽查标准 |
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| 引用本文： | 王少华,王征旭,王豪,王海英,高晨燕,王焕玲,阎昭,林阳,武峰,周焕,刘利军,王瓅珏,刘巧,韩冕,王熳,曹彩. 临床试验通用稽查标准[J]. 现代药物与临床, 2019, 42(6): 1061-1068 |
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| 作者姓名： | 王少华 王征旭 王豪 王海英 高晨燕 王焕玲 阎昭 林阳 武峰 周焕 刘利军 王瓅珏 刘巧 韩冕 王熳 曹彩 |
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| 作者单位： | 中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020,中关村玖泰药物临床试验技术创新联盟, 北京 100020 |
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| 摘 要： | 主要论述《临床试验通用稽查标准》起草背景、目的、制定依据、适用范围、稽查内容与标准、稽查发现问题分级定义等，以期进一步完善临床试验质量管理体系，通过临床试验通用稽查标准的建立与执行，规范临床试验稽查工作，进而促进临床试验领域从业人员工作自律，规范临床试验过程，确保临床试验数据真实、结果可靠，加速我国临床试验研究的国际化进程，提升行业临床试验稽查水平和临床试验能力。
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| 关 键 词： | 临床试验 稽查 标准 |
| 收稿时间： | 2019-04-04 |
The universal standard of clinical trial audit |
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| WANG Shaohu,WANG Zhengxu,WANG Hao,WANG Haiying,GAO Chenyan,WANG Huanling,YAN Zhao,LIN Yang,WU Feng,ZHOU Huan,LIU Lijun,WANG Lijue,LIU Qiao,HAN Mian,WANG Man and CAO Cai. The universal standard of clinical trial audit[J]. Drugs & Clinic, 2019, 42(6): 1061-1068 |
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| Authors: | WANG Shaohu WANG Zhengxu WANG Hao WANG Haiying GAO Chenyan WANG Huanling YAN Zhao LIN Yang WU Feng ZHOU Huan LIU Lijun WANG Lijue LIU Qiao HAN Mian WANG Man CAO Cai |
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| Affiliation: | Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China,Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China and Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100020, China |
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| Abstract: | The universal standard of clinical trial audit mainly discusses the drafting background, the purpose, the basis of formulation, the scope of application, the content and standard of auditing, and the grading of audit findings, etc.The main purpose of this standard is, by improving the quality management system of clinical trials, to standardize the audit work and clinical trial process, enhance the self-discipline of practitioners, ensure the authenticity and reliability of clinical trial data. This standard will accelerate the internationalization of clinical trial in China, raise the bar of clinical trial audit and improve the capibility of clinical trial in China. |
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| Keywords: | clinical trial audit standard |
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