基于临床试验现场管理组织行业发展的临床研究协调员管理现状分析  

Current situation analysis of clinical research coordinator management based on the development of site management organization industry

作　　者：王淑民 李婷[1,2] 裴婕 夏强 冯文利[1,2] 吕亚丽[1,3] WANG Shu-min;LI Ting;PEI Jie;XIA Qiang;FENG Wen-li;LÜYa-li(Department of Pharmacy,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China;Office of Drug Clinical Trial Institution,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China;Office of Institutional Review Board,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China)

机构地区：[1]首都医科大学附属北京朝阳医院,药事部,北京100020 [2]首都医科大学附属北京朝阳医院,药物临床试验机构办公室,北京100020 [3]首都医科大学附属北京朝阳医院,伦理委员会办公室,北京100020

出　　处：《中国临床药理学杂志》2023年第11期1639-1642,共4页The Chinese Journal of Clinical Pharmacology

基　　金：首都卫生发展科研专项基金资助项目(2022-2Z-2038)。

摘　　要：目的研究分析临床研究协调员(CRC)的人员变动情况及工作现状,以期为相关组织与机构提供参考与借鉴。方法通过分析了北京市10家临床试验机构2022-04-01—2022-12-31的760例CRC工作现状以及8家临床试验现场管理组织(SMO)公司2019—2021年的CRC人员情况,用IBM SPSS Statistics 22软件进行统计分析。结果CRC专业均是以药学专业及护理专业为主,学历以本科为主。心内科配备的CRC人数最多,血液内科在研项目数最多,CRC发生交接项目的次数也最多,而眼科的未启动项目数最多。2021年CRC的离职率明显高于2019年和2020年。结论目前,我国CRC协助研究者参与临床试验可以提升临床试验的质量,但还需在行业准入、薪资待遇、岗位晋升、工作环境、平台建设等方面进一步规范和优化,促进我国临床试验事业的发展。Objective To study and analyze the staff changes and working status of clinical research coordinator(CRC)in order to provide reference for related organizations and institutions.Methods The data about the working status of 760 CRC personnel in 10 clinical trial institutions in Beijing from 2022-04-01 to 2022-12-31 and the CRC personnel in 8 clinical trial site management organization(SMO)companies from 2019 to 2021 was collected,IBM SPSS Statistics 22 software was used for statistical analysis of the data.Results The majors of CRC was mainly pharmacy and nursing,and the education background was mainly bachelor.The department of cardiology has the largest number of CRC’s,the department of hematology has the largest number of research projects,and the number of CRC handover projects is also the highest,while the department of ophthalmology has the largest number of unstarted projects.The turnover rate of CRC in 2021 is significantly higher than that in 2019 and 2020.Conclusion At present,Chinese CRC assisted researchers to participate in clinical trials,which can improve the quality of clinical trials,but it needs to be further standardized and optimized in the aspects of industry access,salary,job promotion,working environment,platform construction,etc.,to promote the development of Chinese clinical trials.

关 键 词：临床试验机构 临床试验现场管理组织 临床研究协调员 

分 类 号：R97[医药卫生—药品]