Department of Information Technology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 310003, China.
Research Center for Clinical Pharmacy, Department of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, Hangzhou, 310003, China.
BMC Med Inform Decis Mak. 2023 Apr 6;23(1):61. doi: 10.1186/s12911-023-02158-8.
The process of initiating and completing clinical drug trials in hospital settings is highly complex, with numerous institutional, technical, and record-keeping barriers. In this study, we independently developed an integrated clinical trial management system (CTMS) designed to comprehensively optimize the process management of clinical trials. The CTMS includes system development methods, efficient integration with external business systems, terminology, and standardization protocols, as well as data security and privacy protection.
The development process proceeded through four stages, including demand analysis and problem collection, system design, system development and testing, system trial operation, and training the whole hospital to operate the system. The integrated CTMS comprises three modules: project approval and review management, clinical trial operations management, and background management modules. These are divided into seven subsystems and 59 internal processes, realizing all the functions necessary to comprehensively perform the process management of clinical trials. Efficient data integration is realized through extract-transform-load, message queue, and remote procedure call services with external systems such as the hospital information system (HIS), laboratory information system (LIS), electronic medical record (EMR), and clinical data repository (CDR). Data security is ensured by adopting corresponding policies for data storage and data access. Privacy protection complies with laws and regulations and de-identifies sensitive patient information.
The integrated CTMS was successfully developed in September 2015 and updated to version 4.2.5 in March 2021. During this period, 1388 study projects were accepted, 43,051 electronic data stored, and 12,144 subjects recruited in the First Affiliated Hospital, Zhejiang University School of Medicine.
The developed integrated CTMS realizes the data management of the entire clinical trials process, providing basic conditions for the efficient, high-quality, and standardized operation of clinical trials.
在医院环境中启动和完成临床药物试验的过程非常复杂，存在众多机构、技术和记录保存方面的障碍。本研究独立开发了一个综合临床试验管理系统（CTMS），旨在全面优化临床试验的流程管理。该 CTMS 包括系统开发方法、与外部业务系统的高效集成、术语和标准化协议，以及数据安全和隐私保护。
开发过程经过四个阶段，包括需求分析和问题收集、系统设计、系统开发和测试、系统试运营以及对全院进行系统操作培训。综合 CTMS 包括三个模块：项目审批和审查管理、临床试验操作管理和背景管理模块。这些模块分为七个子系统和 59 个内部流程，实现了全面执行临床试验流程管理所需的所有功能。通过提取-转换-加载、消息队列和远程过程调用服务与医院信息系统（HIS）、实验室信息系统（LIS）、电子病历（EMR）和临床数据存储库（CDR）等外部系统实现高效的数据集成。采用相应的数据存储和数据访问策略确保数据安全。隐私保护符合法律法规，并对敏感患者信息进行去标识化处理。
综合 CTMS 于 2015 年 9 月成功开发，并于 2021 年 3 月更新至 4.2.5 版本。在此期间，浙江大学校医院共接受了 1388 项研究项目，存储了 43051 份电子数据，并招募了 12144 名受试者。
所开发的综合 CTMS 实现了整个临床试验过程的数据管理，为临床试验的高效、高质量和标准化运行提供了基本条件。
