中国临床研究协调员压力源特征研究  

An analysis of job stressors for chinese clinical research coordinators

作　　者：张邦禹 李玉平[2] 张鹏[2] 徐瑛[3] 周斌 ZHANG Bang-yu;LI Yu-ping;ZHANG Peng;XU Ying;ZHOU Bin(China National Pharmaceutical Industry Information Centre,China State Institute of Pharmaceutical Industry,Shanghai 200040,China;Shanghai Pulmonary Hospital Affiliated to Tongji University,Shanghai 200433,China;Shanghai Centre for Drug Evaluation and Inspection,Shanghai 201210,China)

机构地区：[1]中国医药工业研究总院,中国医药工业信息中心,上海200040 [2]同济大学附属上海市肺科医院,上海200433 [3]上海药品审评核查中心,上海201210

出　　处：《中国新药杂志》2020年第15期1752-1756,共5页Chinese Journal of New Drugs

摘　　要：目的:确定临床研究协调员(clinical research coordinator,CRC)工作压力源的构成因素,确定适合我国国情的CRC工作压力源特征。方法:采用文献回顾法、专家咨询法等,经过小范围施测,确定了“工作负荷”、“与研究团队冲突”、“工作模糊”、“与项目团队冲突”、“受试者照护”5个特征因子,23项条目的CRC压力源特征,并进一步检验信度和效度。结果:本研究提出的CRC 5因子压力源特征具有良好的信度和效度。结论:可为管理者了解CRC工作压力情况提供评价工具和干预依据。Objective:To identify the components of clinical research coordinators(CRC)'job stress and analyze the characteristic job stressors.Methods:Based on literature review,consulting and small-scale testing,we identified 5 characteristic job stressors with 23 items for Chinese CRC,composing workload,conflict with research team,work ambiguity,conflict with project team,and care for subject.The reliability and efficacy were assessed.Results:The analysis of characteristic job stressors for Chinese CRC has good reliability and efficacy.Conclusion:The characteristic stressors could be used in understanding the situation of job stress in Chinese CRC and providing evidence for intervention.

关 键 词：临床研究协调员 压力源特征 职业压力 

分 类 号：R95[医药卫生—药学]