| 临床研究药物中心化管理现场评估标准 |
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| 引用本文： | 李树婷,杨丽,张黎,房虹,程金莲,赵侠,阎昭,严海泓,陈勇川,韩志春,孙彬贤,王菁菁,赵丹,曹彩. 临床研究药物中心化管理现场评估标准[J]. 现代药物与临床, 2016, 39(3): 335-344 |
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| 作者姓名： | 李树婷 杨丽 张黎 房虹 程金莲 赵侠 阎昭 严海泓 陈勇川 韩志春 孙彬贤 王菁菁 赵丹 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/中国GCP 联盟, 北京 100034;中关村玖泰药物临床试验技术创新联盟/中国GCP 联盟, 北京 100034;中关村玖泰药物临床试验技术创新联盟/中国GCP 联盟, 北京 100034;中关村玖泰药物临床试验技术创新联盟/中国GCP 联盟, 北京 100034;中关村玖泰药物临床试验技术创新联盟/中国GCP 联盟, 北京 100034;中关村玖泰药物临床试验技术创新联盟/中国GCP 联盟, 北京 100034;中关村玖泰药物临床试验技术创新联盟/中国GCP 联盟, 北京 100034;中关村玖泰药物临床试验技术创新联盟/中国GCP 联盟, 北京 100034;中关村玖泰药物临床试验技术创新联盟/中国GCP 联盟, 北京 100034;中关村玖泰药物临床试验技术创新联盟/中国GCP 联盟, 北京 100034;中关村玖泰药物临床试验技术创新联盟/中国GCP 联盟, 北京 100034;中关村玖泰药物临床试验技术创新联盟/中国GCP 联盟, 北京 100034;中关村玖泰药物临床试验技术创新联盟/中国GCP 联盟, 北京 100034;中关村玖泰药物临床试验技术创新联盟/中国GCP 联盟, 北京 100034 |
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| 摘 要： | 从起草背景、制定依据、检查内容、评估标准、适用范围、评分等级、结果评定等方面阐述《临床研究药物中心化管理现场评估标准》,以期能够切实促进临床研究药物标准化管理,提高药物中心化管理水平。
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| 关 键 词： | 临床研究药物 中心化管理 标准 |
| 收稿时间： | 2015-04-16 |
The standard of on-site inspection for clinical investigational drug centralized management |
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| LI Shu-ting,YANG Li,ZHANG Li,FANG Hong,CHNEG Jin-lian,ZHAO Xi,YAN Zhao,YAN Hai-hong,CHEN Yong-chuan,HAN Zhi-chun,SUN Bin-xian,WANG Jing-jing,ZHAO Dan and CAO Cai. The standard of on-site inspection for clinical investigational drug centralized management[J]. Drugs & Clinic, 2016, 39(3): 335-344 |
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| Authors: | LI Shu-ting YANG Li ZHANG Li FANG Hong CHNEG Jin-lian ZHAO Xi YAN Zhao YAN Hai-hong CHEN Yong-chuan HAN Zhi-chun SUN Bin-xian WANG Jing-jing ZHAO Dan CAO Cai |
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| Affiliation: | ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China;ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China;ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China;ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China;ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China;ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China;ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China;ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China;ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China;ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China;ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China;ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China;ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China;ZhongguancunJiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association, Beijing 100034, China |
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| Abstract: | The standard of on-site inspection for clinical investigational drug centralized management which elaborates from the drafting background, the establishment basis, the inspection content, the assessment standard, the application scope, the rating, the evaluation of the results, etc. The purpose is to improve the standardized management of clinical investigational drug and to push the construction of the frame and the model of the drug centralized management. |
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| Keywords: | clinical investigational drug centralized management standard |
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