临床医师对临床监察员满意度调查分析

Investigation of clinicians＇ satisfaction on clinical research associates

目的探讨临床医师对临床监察员（CRA）的满意度及其影响因素，对CRA的教育提出合理化建议。方法从5所三级甲等医院参加过临床试验的临床医师中随机抽取160名进行问卷调查，调查问卷采用李克特量表（Likertscale）5点测量法，内容包括4个层面12个维度，即工作态度、专业知识和能力、沟通协调能力、项目管理能力。利用SPSS15．0软件进行数据处理和统计分析。用列联表的．）（。分析调查对象的属性特征与其对CRA总体满意度的关联性。结果12项指标均值在2．28～3．75，总体满意度不高。其中，对CRA的服务意识、试验方案熟悉程度和CRF填写方面的满意度最高，分别为74．04％、61．70％，其余10项指标的满意度均〈50．00％。卡方分析结果显示，性别、学历、职称与总体满意度没有关联；参加过和未参加过培训的人员的总体满意度存在差异（P〈0．05），参与试验数量不同的人员之间总体满意度也存在显著差异（P〈0．01）。结论临床医师对CRA的总体满意度不高，通过加强CRA的培训、建立CRA职业资格准入制度和加强临床医生对临床试验的重视和临床试验的能力以规范临床试验行业发展，提高我国的临床试验水平。

Objective To investigate the satisfaction of clinicians on clinical research associates （CRA）and its influencing factors, for the purpose of providing rationalized proposals on education of CRAs. Methods 141 clinicians were randomly sampled from tertiary hospital for questionnaire survey, using the 5-point Likert scale. The survey covers 4 levels, i. e., the work attitude, professional knowledge and ability, communication skills, and project management capabilities, as well as 14 dimensions. Data processing and statistics were analyzed using SPSS 15.0 software. The attribute characteristics of the investigation subjects were analyzed using X2 of the contingency table, along with analysis of its correlation with the general satisfaction on CRAs. Results The mean values of the 12 indicators range 2. 28 to 3.75 ,with low satisfaction in general. Among these indicators, satisfaction of the service attitude of the CRA, and of their familiarity with the pilot program and CRF completion are the highest, respectively, 74. 04% and 61.70%. Satisfaction of the rest 10 indicators falls below 50. 00%. The chisquare analysis showed no association between satisfaction and gender, education, job titles. The satisfaction is different（P〈0. 05） between those trained and those not, while there exists a significant differences（P〈0. 01）between those participating in different number of tests. Conclusion Clinicians have a low satisfaction on CRAs. It is recommended to strengthen the training, establish a CRA occupation certification system, and to strengthen the clinicians＇ emphasis and competency of clinical trials. These actions will normalize the industry of clinical trials and improve the level of clinical trials in China.