院外临床研究协调员“院内化”及其在试验质量管理中的作用  

Analysis of Converting Non-hospital Clinical Research Coordinators to 'Hospital Staffs' and Their Role in the Quality Management of Clinical Trials

作　　者：曹端文 刘小健[1] 涂颖秋[1] 魏筱华[1] CAO Duanwen;LIU Xiaojian;TU Yingqiu;WEI Xiaohua(Clinical Trial Center,Department of Pharmacy,the First Affiliated Hospital of Nanchang University,Nanchang 330006,China)

机构地区：[1]南昌大学第一附属医院药学部GCP中心,南昌330006

出　　处：《医药导报》2018年第11期1426-1429,共4页Herald of Medicine

基　　金：国家自然科学基金资助项目(81660591);南昌大学第一附属医院博士科研启动基金(700873001)

摘　　要：该文通过探讨研究机构质量管理现状,结合当前临床试验的质量要求和临床研究协调员的工作特点及发展态势,分析和讨论了将院外临床研究协调员进行"院内化"的重要性与必要性,并归纳了院内化常用方法。结合该院实际情况,分析了院内化临床研究协调员在质量管理体系中的角色定位及其工作内容,以达到优化临床试验质量管理流程和提高质量的目的。According to the quality requirements of clinical trials and the work characteristics and the development trend of clinical research coordinators （CRCs）,we proposed that converting non-hospital CRCs to hospital CRCs or ‘hospital Staffs’ and arranging them to assist quality management in clinical trials are very important and significant for improving the quality of clinical trials.In present study,we also analyzed the methods about how to convert non-hospital clinical research coordinators to hospital CRC and briefly described their role in quality management.

关 键 词：临床试验 临床研究协调员 质量管理 

分 类 号：R95[医药卫生—药学]