临床试验中的数据问题及改进措施探讨——基于某三甲医院CRC工作考核  

Discussion of data problems and improvement measures in clinical trials:Based on CRC work assessment in a grade A tertiary hospital

作　　者：刘飞 王情情 赵海娟[1] 姚慧卿[1] 苗苗[1] 刘岳[1] 王艳惠 王欣[1] Liu Fei;Wang Qingqing;Zhao Haijuan;Yao Huiqing;Miao Miao;Liu Yue;Wang Yanhui;Wang Xin(Clinical Trial Center,Beijing Hospital、National Center of Gerontology、Institute of Geriatric Medicine,Chinese Academy of Medical Science、Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Exaluation,Beijing 100730,China;Human resource department of Beijing hos pital、National Center of Gerontology、Institute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing 100730,China)

机构地区：[1]北京医院临床试验研究中心、国家老年医学中心、中国医学科学院老年医学研究院、药物临床风险与个体化应用评价北京市重点实验室,北京100730 [2]北京医院人事处、国家老年医学中心、中国医学科学院老年医学研究院,北京100730

出　　处：《中华医学科研管理杂志》2022年第6期416-420,共5页Chinese Journal of Medical Science Research Management

基　　金：中国医学科学院医学与健康科技创新工程临床试验及临床试验机构评价体系建设与应用研究(2021-1-12M-045);2022年度首都卫生发展科研专项(首发2022-2Z-4055)。

摘　　要：目的CRC(临床研究协调员)负责临床试验数据的转录和核对,通过对CRC工作考核发现的数据问题进行分析和讨论,就临床试验数据问题向研究机构、申办者提出建议,进而提高临床试验的质量。方法根据ALOCA+原则,分析北京某三甲医院在2018年11月至2021年12月期间开展的基于临床试验质量的CRC考核中发现的数据问题,探讨针对临床试验数据问题的改进措施。结果在临床试验数据问题中,数据的完整性问题最为突出,其次是准确性问题。结论研究机构和申办者均应完善数据管理的制度和SOP,加强对临床试验参与者的培训,优化试验方案和流程设计,加强监查,建立基于风险的质控体系,使临床试验数据符合国际ALOCA+原则,使临床试验结果准确可靠。Objective The Clinical Research Coordinator(CRC)is responsiblefor transcribing and verifying clinical trial data,and making recommendations to research institutions and sponsors on clinical trial data through analyzing and discussing data problems found in CRC work assessment,thereby improving the quality of clinical trials.Methods Based on the ALOCA+Principle,this study analyzed the data problems found in CRC assessment based on clinical trial quality conducted in a grade A tertiary hospital in Beijing from November 2018 to December 2021,and discussed improvement measures for clinical trial data problems.Results Among the clinical trial data problems,data integrity is the most prominent,followed by accuracy.Conclusions Research institutions and sponsors should improve the data management system and SOP,strengthen the training for clinical trial participants,optimize a trial plan and process design,strengthen supervision and inspection,and establish a riskbased quality control system,etc.,so as to make clinical trial data conform to the international ALOCA+principle and make clinical trial resultsaccurateand reliable.

关 键 词：临床试验数据 数据完整性 ALOCA+原则 临床研究协调员 

分 类 号：R197.323[医药卫生—卫生事业管理]