中国药物警戒 ›› 2019, Vol. 16 ›› Issue (12): 711-715.
DOI: 10.19803/j.1672-8629.2019.12.02

• 法规与管理研究 • 上一篇    下一篇

疫苗临床试验电子数据信息采集系统的研发与安全性监测

梁馨元1, 莫毅1, 冯硕2, 杨焕3,*, 莫兆军1   

  1. 1广西壮族自治区疾病预防控制中心,广西 南宁 530028;
    2广西百高宏志科技有限责任公司,广西 南宁 530028;
    3国家药品监督管理局药品审评中心,北京 100022
  • 收稿日期:2019-12-18 修回日期:2019-12-18 出版日期:2019-12-15 发布日期:2019-12-18
  • 通讯作者: *杨焕,女,高级审评员,研究员,新药临床评价。E-mail: yangh@cde.org.cn
  • 作者简介:梁馨元,女,硕士,助理研究员,疫苗临床研究。
  • 基金资助:
    国家科技重大专项-重大新药创制（2015ZX09501008-008）：疫苗生物类似物临床试验用数据信息采集系统的建立

Development and Safety Monitoring of Electronic Data Capture System for Vaccine Clinical Trials

LIANG Xinyuan1, MO Yi1, FENG Shuo2, YANG Huan3, MO Zhaojun1   

  1. 1Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control, Nanning Guangxi 530028, China;
    2Guangxi Baigao Hongzhi Scientific Technology Co., Ltd. Nanning Guangxi 530023, China;
    3Center for Drug Evaluation of National Medical Products Administration, Beijing 100022, China
  • Received:2019-12-18 Revised:2019-12-18 Online:2019-12-15 Published:2019-12-18

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摘要： 目的 解决传统的纸质载体数据采集存在无法保证数据的可靠性和安全性、采集周期过长、成本高等不足,对疫苗临床试验电子数据采集系统应用及数据安全性监测进行积极的探索。方法 设计研发适于中国国情的疫苗临床试验专用的数据信息采集（EDC）系统。该系统由计算机及其相关配套设备、设施构成,按一定的应用目标和规则对数据信息进行收集及处理。在广西一个疫苗临床试验现场对各个功能模块进行全面、严格、规范的验证。结果 运行测试结果表明该系统可实现疫苗临床试验使用的电子病历报告表(eCRF)等临床试验数据录入、审核、统计以及数据导出,特别用于疫苗临床试验现场的安全性监测和数据收集,可在线实时监测受试者随防状态及AE发生情况。结论 本系统的研发运用可满足国内疫苗临床试验的专业需求及二次开发需求,有利于对疫苗临床试验数据质量的监管和安全性监测,为疫苗大规模人群临床研究建立系统的疫苗类药物警戒体系奠定基础。

关键词: 电子数据信息采集系统, 疫苗临床试验, 安全性, 数据质量

Abstract: Objective To solve the existing problems with traditional paper-based data collection, such as poor security and liability, slow data aggregation and high cost, and to explore the application of the Electronic Data Capture (EDC) System and data safety monitoring. Methods An Electronic Data Capture (EDC) System was designed that was specifically used for vaccine clinical trials based on Chinese standards and requirements. With an integrated hardware and software solution, the man-machine system was able to collect and process data according to certain application Objectives and rules. Each of the functional modules was verified in a comprehensive, rigorous and standard way on one of the clinical trial sites in Guangxi. Results The system proved to be capable of recording and storing information, querying and verifying data, statistical analysis and data-derivation, which could ensure vaccine safety monitoring and data collection by means of online real-time monitoring of the subjects’ follow-up visit status and adverse events. Conclusion This EDC system can not only meet the needs of Chinese vaccine clinical trials and the second development, but provide a platform in support of large sample clinical trial monitoring and management as well as safety monitoring, thus layinga solid foundation for establishing systematic vaccine-drug pharmacovigilance systems.

Key words: electronic data capture system (EDC), vaccine clinical trial, safety, data quality

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