【作者】 王丽丽； 梁虹； 张菁； 王倩倩； 何金杰； 陈渊成； 郁继诚； 张骥胤；

【Author】 WANG Li-li;LIANG Hong;WANG Qian-qian;ZHANG Jing;HE Jin-jie;CHEN Yu an-cheng;YU Ji-cheng;ZHANG Ji-yin;Laboratory of Phase Ⅰ Clinical Research,b.Drug Clinical Trials Institution,Huashan Hospital,Fudan University;

【机构】 复旦大学附属华山医院,Ⅰ期临床研究室；

【摘要】 目的分析Ⅰ期临床试验临床研究协调员(Clinical Research Coordinator,CRC)录入电子病历报告表产生数据质疑的原因,提出防范对策,以期提高临床试验电子数据录入的准确性。方法采用三个创新药Ⅰ期临床试验项目,由申办方数据管理部门提供的电子数据质疑报表,分析数据质疑在试验不同阶段、不同模块的分布,以及错误类型进行分类统计分析,提出相应对策持续改进。结果①临床试验进程中数据质疑最易发生在随访期占66.78%;②系统自动触发型质疑占比最高,人工逻辑核查型质疑最具分析意义;③人工逻辑核查型质疑中,文本型错误发生频数最高,占47.53%,其次为逻辑错误和页面相关错误。发生率最高的三个模块分别为实验室检查占41.25%、生命体征/心电图占比14.64%、不良事件/合并用药占比9.36%;④CRC缺乏责任心、专业能力薄弱、是导致质疑产生的最主要因素。结论 CRC录入数据过程中,应重点提高其工作责任心,加强对信息化系统的使用和专业知识的培训,保证试验数据的真实完整,降低CRC数据录入错误的发生率。更多还原

【Abstract】 AIM To analyze the reasons why the clinical research coordinator(CRC) of phase I clinical trial entered the electronic medical record report form to question the data,and to propose preventive countermeasures,in order to improve the accuracy of electronic data entry of clinical trials.Methods Three innovative drug phase I clinical trial projects were used,and the electronic data challenge report provided by the sponsor’s data management department was used to analyze the distribution of data challenges in different stages of the trial,the distribution of different modules,and the types of errors for classification and statistical analysis,and put forward corresponding countermeasures.Improve.Results ①In the course of the clinical trial,data questioning was most likely to occur during the follow-up period,accounting for 66.78%;②The system automatic triggering type questioning accounted for the highest proportion,and the manual logic checking type questioning was the most analytically meaningful;③In the manual logic checking type questioning,text-based errors occurred The frequency is the highest,accounting for47.53%,followed by logic errors and page-related errors.The three modules with the highest incidence rate were laboratory examinations accounting for 41.25%,vital signs/ECG accounting for 14.64%,and adverse events/concomitant medication accounting for 9.36%;④CRC lacks responsibility and professional ability,which is the most important factor leading to doubts.major factor.Conclusion In the process of CRC data entry,the focus should be on improving their sense of responsibility,strengthening the use of information systems and training of professional knowledge,ensuring the authenticity and integrity of test data,and reducing the incidence of CRC data entry errors.更多还原