我国药物临床试验临床监查员胜任素质模型构建

Establishment of competency model for clinical research associates in drug clinical trials in China

目的:构建我国药物临床试验临床监查员胜任素质模型。方法:通过文献分析和逻辑分析等方法初步获得临床监查员的胜任素质要素,在此基础上用问卷调查法对绩优组和一般组的临床监查员进行调查,通过使用SPSS 18.0进行结果分析。结果与结论:构建了由知识、技能/能力、职业素养3个维度以及11项胜任素质要素组成的我国药物临床试验临床监查员的胜任素质模型。

Objective：To establish the competency model for clinical research associates in drug clinical trials in China. Methods：Firstly,the competency elements for clinical research associates were defined through literature research and logic analysis,etc. Then the clinical research associates in the groups of outstanding performance and general performance were investigated,and the results were analyzed by using SPSS 18. 0.Results Conclusion：The competency model for clinical research associates in drug clinical trials in China was established,which consists of three dimensions（knowledge, skills/competencies, professionalism） and 11 competency elements.