文件受控管理是近年来药物临床试验管理的热点和要点，传统人工文件受控管理效率低，工作量大，本研究设计了一套全新的文件受控管理系统，通过自动信息化手段为药物临床试验机构文件受控减负。系统通过C/S通讯模式达到文档电子存储与区域流转，加入智能检索功能，解决传统纸质文件不易管理情况，并通过UUID对文件唯一性进行标识，实现受控管理。通过建立文件受控管理系统，实现纸质文件受控管理，初步测试系统功能稳定，临床试验文件受控工作效率得到提升。电子化文件受控管理可实现用户账号追踪，各操作流程均保留轨迹记录，实现全流程受控管理，使临床试验的开展更加规范、科学和有序，值得今后进一步推广应用。

Document controlled management is a hot topic and key point in drug clinical trial management in recent years, traditional manual document controlled management is inefficient and requires a large workload, this study designed a new set of document controlled management system to reduce the burden of drug clinical trial institutions by automatic information means. The system achieves electronic storage and regional flow of documents through C/S communication mode, adds intelligent retrieval function to solve the difficulty of paper management, and identifies the uniqueness of documents through UUID to achieve controlled management. By implementing this document controlled management system to achieve the controlled management of paper documents, and also preliminary system test function is stable, leading to improved work efficiency in clinical trial document control. The electronic document controlled management system can track user account, keep track records of each operation process and achieve controlled management of the whole process, which makes the development of clinical trials more standardized, scientific and orderly, and is worthy of further promotion and application in the future.

R951

广东省医学科学技术研究基金项目(A2023474)