药物临床试验机构文件受控管理现状及调查分析  

Investigation and analysis on the management status of document control in drug clinical trial institutions

作　　者：陈娜[1] 蔡雪玲 叶穗雯[2] 潘芸芸 曾参[4] 吕丽虹[1] 孙萍萍[5] 戴婕[1] 沈杰 邹燕琴[1] CHEN Na;CAI Xue-ling;YE Sui-wen;PAN Yun-yun;ZENG Shen;LV Li-hong;SUN Ping-ping;DAI Jie;SHEN Jie;ZOU Yan-qin(Drug Clinical Trial Institution,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510000,China;Phase Ⅰ Clinical Trial Center,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510000,China;Clinical Pharmacy Center,Nanfang Hospital,Southern Medical University,Guangzhou 510000,China;Drug Clinical Trial Institution,Guangzhou First People's Hospital,Guangzhou 510000,China;Drug Clinical Trial Institution,The First Affiliated Hospital,Sun Yat-Sen University,Guangzhou 510000,China;Phase Ⅰ Ward,Chongqing University Cancer Hospital,Chongqing 400030,China)

机构地区：[1]中山大学孙逸仙纪念医院药物临床试验机构,广州510000 [2]中山大学孙逸仙纪念医院Ⅰ期临床研究中心,广州510000 [3]南方医科大学南方医院临床药学中心,广州510000 [4]广州市第一人民医院药物临床试验机构,广州510000 [5]中山大学附属第一医院药物临床试验机构,广州510000 [6]重庆大学附属肿瘤医院Ⅰ期病房,重庆400030

出　　处：《中国新药杂志》2024年第13期1362-1369,共8页Chinese Journal of New Drugs

摘　　要：目的:了解临床试验中文件受控管理的现状及存在的问题,为药物临床试验机构的临床试验文件受控管理提供参考。方法:以全国71家药物临床试验机构为调查对象,采用问卷调查方式,围绕药物临床试验机构及临床试验项目开展文件受控管理基本情况、受控管理文件范畴、文件受控管理方式、文件受控管理的问题及难点等方面进行调查。结果:本次调研涉及全国13个省、市、自治区的71家药物临床试验机构,共收回71份问卷,调查发现94.37%的机构已实现文件受控管理,其中25.37%采用电子系统进行文件受控,超过95%的受访者认为应进行受控管理且做到唯一、不可替换的纸质记录文件有:肿瘤评估表、受试者日记卡、药物管理表格。目前文件受控管理方式存在工作量大、难以实现闭环受控、电子受控系统保密性较差等问题。结论:对调研结果进行分析并结合各类文件在临床试验过程中的重要性提出将受控文件分为:一般受控文件、重要受控文件、核心受控文件3个受控管理级别,根据受控分级给出相应受控管理建议,以明确临床试验文件受控管理重点,提高临床试验文件管理效率及质量。Objective:To investigate the status and potential problems in the management of document control in clinical trials,providing reference for the management of document control in drug clinical trial institutions.Methods:Questionnaire survey was conducted in 71 drug clinical trial institutions in China.The questionnaire focused on the basic situations,the scope,the method,problems and difficulties that are involved in the management of document control in drug clinical trial institutions and clinical trial programs.Results:The survey included 71 drug clinical trial institutions located in 13 provinces,municipalities and autonomous regions in China.A total of 71 questionnaires were obtained.The survey found that 94.37%of the institutions have achieved the management of document control,25.37%have applied electronic system in the management of document control,≥95%of respondents considered that the paper records should be controlled management and that was taken as unique and irreplaceable included tumor evaluation form,subject diary card and drug management form.At present,there are problems in the management method of document control,including heavy workload,impossibility of closed-loop control and poor confidentiality of electronic controlled system.Conclusion:Through the analysis of the survey results and the importance of various documents in clinical trials,the controlled documents are proposed to divide into three controlled management levels of general controlled documents,important controlled documents and core controlled documents.According to the classification of controlled documents,the survey makes corresponding recommendations in controlled management,identifying priorities in the management of document control and improving the efficiency and quality of document management in clinical trials.

关 键 词：药物临床试验 文件受控 受控管理 问卷调查 

分 类 号：R927[医药卫生—药学]