临床试验研究者对协调员的满意度及管理对策探讨  

Clinical trial investigators＇ satisfaction with clinical research coordinators and discussion on managing strategy

作　　者：王欣[1] 姚慧卿[1] 刘丽[2] 李雪宁[3] 赵海娟[1] 张可欣 杜元太[1] Wang Xin;Yao Huiqing;Liu Li;Li Xuening;Zhao Haijuan;Zhang Kexin;Du Yuantai(Beijing Hospital, National Center of Gerontology, Beijing 100730, China)

机构地区：[1]北京医院国家老年医学中心,100730 [2]吉林大学第一医院 [3]复旦大学附属中山医院

出　　处：《中华医院管理杂志》2018年第7期604-608,共5页Chinese Journal of Hospital Administration

摘　　要：目的了解研究者对临床研究协调员（CRC）的满意度，发现CRC行业或者机构管理中存在的不足并加以改进。方法2018年1月，对3所三级甲等综合性医院的120名临床试验研究者进行了问卷调查，问卷包含3个部分：基本情况、对CRC满意度以及研究者对CRC工作其他情况的评价。对所得数据进行描述性分析，计数资料比较采用Fisher精确检验。结果研究者对CRC的满意度整体较高，“责任心”“工作时间充足”“熟悉GCP法规”等方面，满意度为72．6％-83．2％；“主动性”“工作稳定性”“临床试验经验丰富”等方面，满意度则低于60．0％。CRC的来源与“主动性”（P=0．007）、“熟悉临床试验方案和试验流程”（P=0．043）的满意度有相关性，研究者对来源不确定的CRC的满意度显著降低；研究者经验与CRC“熟悉GCP法规”的满意度有相关性（P=0．035），研究者经验越丰富，满意度越低。结论医疗机构应建立CRC规范化培训体系及分级认证体系，规范机构对CRC的聘用模式并严格控制聘用标准；提高机构经费预算能力，使CRC费用合理充足；加强医院各职能处室对CRC的统一管理，以提高研究者效率、保障临床试验质量。Objective To learn the investigators＇ satisfaction with CRCs and to identify the shortcomings with the CRC industry or institutional management for improvement. Methods A questionnaire survey was conducted among 120 clinical trial investigators at three tertiary general hospitals in January 2018. The questionnaire covered the basics, satisfaction with C RC, and comments of the investigator on other works of the CRC. The data acquired were subject to descriptive analysis, and the count data comparison method was Fisher precise test. Results The investigators were satisfied with CRCs in general. Specifically, their satisfaction with the ＂ sense of responsibility＂ , ＂ work hours＂ , and ＂ command of GCP protocols＂ ranged 72. 6% to 83.2%. That with ＂initiative＂ , ＂work stability＂, and ＂rich clinical trial experience＂ fell below 60. 0%. Affiliation of CRCs was correlated to ＂ initiative＂ （ P = 0. 007 ）, and ＂ command of clinical trial schemes and trial procedures＂ （ P = 0. 043 ） , while investigators＇ satisfaction with CRCs of uncertain affiliation fell significantly. Investigators＇ experience was correlated to the ＂ command of GCP protocols＂ of CRCs（P = 0. 035）, as the more experienced the investigator, the less their satisfaction with the CRC. Conclusions Hospitals are expected to build a CRC standardized training system and hierarchical certification system; to standardize their CRC recruitment mechanism for overall management; to enhance their budgeting capability for sufficient CRC expenses, higher investigator efficiency and assured clinical trial quality.

关 键 词：问卷调查 药物临床试验 协调员 满意度 培训 

分 类 号：R197.3[医药卫生—卫生事业管理]