美国临床检查员职业化制度的经验与启示  

Experience and inspirations from United States clinical inspector professionalization system

作　　者：任旭 吴方[1] 于倩 徐杨燕 王方敏 REN Xu;WU Fang;YU Qian;XU Yang-yan;WANG Fang-min(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing JIANGSU 211198,China;Shanghai Center,for Drug Eraluation and Inspection,SHANGHAI 201203,China)

机构地区：[1]中国药科大学国际医药商学院,江苏南京211198 [2]上海药品审评核查中心,上海201203

出　　处：《中国新药与临床杂志》2020年第4期207-211,共5页Chinese Journal of New Drugs and Clinical Remedies

基　　金：教育部人文社会科学研究青年基金项目(19YJC630183);江苏省高校哲学社会科学研究一般项目(2019SJA0058);沈阳药科大学亦弘商学院“我国临床检查员胜任力素质研究”课题。

摘　　要：美国已建立起成熟的临床检查员职业化制度,包括完善的培训体系、详实的工作指南及清晰的检查流程等多个方面。本文通过借鉴美国对临床检查员的管理,总结制定科学的选拔依据、形成多样化的培训体系、建立明确的职责体系、设置有效的团队沟通机制等经验启示,为进一步推进我国临床检查员职业化专业化队伍建设提供依据。The United States has established a mature professional system of clinical inspectors, including a comprehensive training system, detailed work guidelines, clear inspection procedures and so on. Based on the US management of clinical inspectors, suggestions were put forward such as developing scientific selection basis, forming a diverse training system, establishing a clear responsibility system, and setting up an effective team communication mechanism, in order to further promote the professionalization team building of Chinese clinical inspectors.

关 键 词：美国 临床试验 检查员 职业化 启示 

分 类 号：R951[医药卫生—药学]