| 引用本文: | 郭彩会,宋浩静,李亚静,孙雪,李颖,董占军.信息管理系统在I期临床试验质量控制中的作用[J].中国现代应用药学,2020,37(1):104-109. |
| GUO Caihui,SONG Haojing,LI Yajing,SUN Xue,LI Ying,DONG Zhanjun.Effect of Drug Clinical Trials Information Systems in Quality Control Phase I Clinical Trial[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(1):104-109. |
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| 摘要: |
| 目的 探讨药物临床试验信息管理系统在I期临床试验质量控制中的作用。方法 在2017年8月-2018年8月的4个Ⅰ期临床试验项目中应用药物临床试验信息管理系统，根据"药物临床试验数据现场核查要点"分析机构质控员与申办方监查员在原始数据核查及质量控制中发现的问题，与传统纸质记录管理模式的4个I期临床试验项目分析比较。结果 使用药物临床试验信息管理系统后的I期临床试验项目中发生的受试者的筛选/入组数据链完整性、临床试验检查/化验等数据的溯源、试验用药品管理过程与记录、受试者的管理等方面存在问题均明显低于系统使用前（χ2=11.922，P<0.001）。结论 药物临床试验信息管理系统在I期临床试验项目中的应用对受试者信息完整性，药品管理规范性，临床试验的真实性、完整性、可信性及可溯源性都有较大提升，能提升I期临床试验的质量。 |
| 关键词: 临床试验 信息系统 I期临床试验 质量控制 |
| DOI：10.13748/j.cnki.issn1007-7693.2020.01.021 |
| 分类号:R951 |
| 基金项目:2019年度河北省医学科学研究课题计划项目（20190274） |
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| Effect of Drug Clinical Trials Information Systems in Quality Control Phase I Clinical Trial |
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GUO Caihui1, SONG Haojing1, LI Yajing1,2, SUN Xue1, LI Ying1, DONG Zhanjun1
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1.Department of Pharmacy, Hebei General Hospital, Shijiazhuang 050051, China;2.Graduate School, Hebei Medical University, Shijiazhuang 050017, China
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| Abstract: |
| OBJECTIVE To investigate the application of drug clinical trial information management system in quality control of phase I clinical trials. METHODS The drug clinical trial information management system was applied in the four Phase I clinical trials from August 2017 to August 2018. According to "the key points of onsite drug clinical trial inspection", the problems found in the original data verification and quality control were analyzed and it was compared with four phase I clinical trials of the traditional paper record management model. RESULTS Problems occurred in data integrity of subjects' screening/inclusion, data traceability of clinical trial inspection/assay, management and records of trial drug, and subject management were significantly lower after the use of the drug clinical trial information management system(χ2=11.922, P<0.001). CONCLUSION The application of drug clinical trial information management system in Phase I clinical trial projects guaranteed the integrity of the information, the standardization of drug management, the authenticity, integrity, credibility and traceability of clinical trials, and can improve the quality of Phase I clinical trials. |
| Key words: clinical trial information systems phase I clinical trial quality control |
