摘要
自我国专业化、职业化的临床检查员队伍建设启动后,临床检查员的核心胜任素质逐渐成为各方关注的焦点。本研究采用行为事件访谈和双三角验证分析我国临床检查员检查任务及职业发展要求,建立了涵盖认知、帮助与服务、个人效能、成就与行动及管理5大范畴的我国临床检查员核心胜任素质模型,以配合当前我国临床试验监管对临床检查员队伍建设的需要。
Since the establishment of a professional and professional clinical inspector team in my country, the core competency of clinical inspectors has gradually become the focus of attention of all parties. This study adopted the behavioral event interview and the double-triangular verification to analyze the inspection tasks and professional development requirements of clinical examiners in our country,and established the coverage of cognition, help and service, personal effectiveness, achievement and action and management. The core competency model of clinical inspectors in China with five major categories is expected to meet the current needs of our country’s clinical trial supervision for the construction of clinical inspectors.
作者
吴方
于倩
王康冉
张象麟
王方敏
宋福鱼
WU Fang;YU Qian;WANG Kang-ran;ZHANG Xiang-lin;WANG Fang-min;SONG Fu-yu(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing JIANGSU 211198,China;School of Yeehong Business,Shenyang Pharmaceutical University,BEIJING 100055,China;Shanghai Center for Drug Evaluation and Inspection,SHANGHAI 201203,China;Center for Food and Drug Inspection of National Medical Products Administration,BEIJING 100044,China)
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2021年第1期25-29,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。
关键词
临床试验
检查员
核心胜任素质
双三角验证
行为事件访谈
clinical trial
inspectors
core competency
double-triangular verification
behavioral event interview
