医疗机构临床研究协调员的管理现状  

Management status of clinical research coordinators in medical institutions

作　　者：侍培培 张全[1] 孙明敏[1] 王辉[1] 赵俊[1] 柴怡[1] SHI Pei-pei;ZHANG Quan;SUN Ming-min;WANG Hui;ZHAO Jun;CHAI Yi(The First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,Jiangsu Province,China)

机构地区：[1]南京医科大学第一附属医院,江苏南京210029

出　　处：《中国临床药理学杂志》2023年第7期1046-1049,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：近年来,临床研究协调员(CRC)作为研究者的助手在临床试验的实施和质量管理过程中发挥着越来越重要的作用,因此,CRC的管理也成为各家药物临床试验机构项目管理的重要内容之一。目前由于尚无标准的CRC管理模式,各研究机构中CRC来源多渠道共存,人员多、流动快,给各研究机构的项目管理带来了难度。本院药物临床试验机构采用的是接受现场管理组织(SMO)派遣CRC的模式,在近年的CRC管理中积累了部分实践经验且行之有效,现简单介绍本机构的CRC管理模式及内容,供其他药物临床试验机构参考。In recent years,the clinical research coordinator(CRC),as an investigator’s assistant,has played an increasingly important role in the implementation and quality management of clinical trials.Therefore,the management of CRC has become an important part of the project management of drug clinical trial institutions.At present,no standard CRC training and certification system has been established in China.Multiple sources of CRC exist in various research institutions,and the large number of personnel and the fast flow bring difficulties to the management of various research institutions.Our drug clinical trial institution adopts the mode of accepting CRC dispatched by site management organization(SMO).We have accumulated practical experience in CRC management in recent years and it is effective.Now we briefly introduce the CRC management mode and content of our institution for reference of other drug clinical trial institutions.

关 键 词：临床试验 现场管理组织 临床研究协调员 

分 类 号：R95[医药卫生—药学]