大型综合医院临床研究伦理审查信息管理系统的设计与实现

Design and implementation of information management system for clinical research ethics review in large general hospitals

目的探讨涉及人体临床研究伦理审查信息管理系统在伦理审查工作中的设计与实现。方法依据ICH—GCP、临床试验管理规范（GCP）、《涉及人体的生物医学研究伦理审查办法》及符合亚太地区SIDCER认证标准的标准操作规程及笔者工作经验进行系统设计与实现结果根据实际工作流程设计实现了伦理管理系统“研究者一管理业务人员一评审专家”三位一体的实时在线互动工作模式，为下一步系统的优化升级奠定基础。结论伦理审查信息管理系统应用使审查管理工作科学、高效，提升伦理审查质量，为医学科学事业的健康发展提供保障。

Objective Discussing the approach to design and implementation of ethical review information management system in clinical research involving human subject. Methods Systematic design and implementation based on ICH-GCP, Chinese GCP, Ethical review of biomedical research in- volving human subjects, Standard Operating Procedure compliant with Asia Pacific SIDCER certifica- tion standards, as well as the working experiences of author group. Results According to the specific working procedures in Beijing e-plugger Support Technology Co. Ltd, We implement ethical manage- ment system with real-time online interactive work model among investigators, ethical committee sec- retariat and ethical reviewers, which is prepared for further system optimization and upgrade. Conclu- sions The application of ethical review information management system make the ethical management work more reliable, efficient, and also improve the quality of ethical review, which helps a lot in safe- guarding the development of medical science.