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Cultural environment and development of CRC and SMO in China

中国临床研究助理的生态环境及现场管理组织发展报告

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收录情况: ◇ 统计源期刊 ◇ 北大核心 ◇ CSCD-C

机构: [1]临床研究促进公益基金( 北京世纪慈善基金会) ,北京100062 [2]北京联斯达医药科技发展有限公司, 北京100123 [3]北京鼎晖思创医药研究有限公司,北京100024 [4]普蕊斯( 上海) 医药科技开发股份有限 公司,上海200001 [5]杭州思默医药科技有限公司,杭州310051 [6]西斯比亚( 北京) 医药技术研究有限 责任公司,北京102206 [7]北京诺为力创医药科技发展有限公司,北京100124 [8]北京卓越天使医药科技 发展有限公司,北京100054 [9]南京西姆欧医药科技有限公司,南京210046 [10]首都医科大学附属北京 安贞医院,北京100029 [11]复旦大学附属肿瘤医院,上海200433 [12]北京大学第三医院,北京100191 [13]北京医院,国家老年医学中心,北京100730 [14]上海津石医药科技有限公司,上海200025
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关键词: Clinical research assistant Clinical research coordinator (CRC) Clinical trial Good clinical practice (GCP) Institution management New drug development Site management organization (SMO)

摘要:
Clinical research assistants/coordinators (CRC) have played an increasingly important role in the new drugs clinical trials in recent years. They have undertaken most of the non-medical judgment work, become an important link among investigators, sponsors and clinical trial centers, and been an important force in accelerating enrollment and ensuring quality of clinical trials. CRC is a new career, so it is very important for us to have more concern and understanding in order to develop this team successfully. Based on the results of 10 questionnaires conducted since establishment of "China CRC Home" in 2014, comparing and analyzing the data of different years, this paper describes the culture environment of CRC and SMO (site management organization, SMO) from 11 aspects including CRC/SMO's development track, their personnel composition and distribution in major cities, CRC's personnel management and SMO's commercial mode, major ways of personnel training, and so on. The status of CRC is outlined in all aspects in this paper. The aim is not only letting more investigators know their assistants, but also paying more attention to the cultivation of CRC at that the whole pharmaceutical industry. So that this young team can grow and develop in a better environment and become a strong basic force for new drugs development in China. © 2018, Chinese Journal of New Drugs Co. Ltd. All right reserved.

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第一作者:
第一作者机构: [1]临床研究促进公益基金( 北京世纪慈善基金会) ,北京100062
通讯作者:
通讯机构: [14]上海津石医药科技有限公司,上海200025
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