近年来，临床试验实施范式和监管模式正在从实施现场至线上远程发生重大转型。临床试验机构借助数智化手段突破发展瓶颈，不仅能提高临床试验全流程管理效率，实现提质增效导向，更能为医疗机构构建差异化、控制风险、保障质量、提升核心竞争力奠定基础。去中心化临床试验（DCT）、临床试验远程监查等目前已成为智能常态化临床试验运营管理新模式，在我国也已形成一定的应用规模，相关实践共识不断发布。为呈现“数据可视、风险可控、质量可验”的数智化优势，同时进一步为我国临床试验远程监查相关工作实施、优化数智化监管提供实证参考与指引，本研究以南方医科大学南方医院临床试验远程监查平台运营实践为例，在梳理远程监查平台建设技术要求与架构的基础上，探讨远程监查的管理路径，剖析远程监查实施效益，显著降低临床试验运营成本、有效优化监查工时配置与时间利用度、提升监查工作质量、具备绿色低碳效益；并针对所发现问题提出相关建议：远程监查可通过构建源数据索引地图形成完整数据溯源链条、制定统一的文件命名及分类规则保障资料标准化管理、以权限控制与轨迹监测强化操作管控规范远程监查平台管理，依托远程监查平台联通多院区间协同质量管理、凭借差异化优势进一步提高机构数智化管理水平，实践高质高效的临床试验运营管理新模式。

 In recent years， the implementation paradigm and regulatory model of clinical trials have undergone a major transformation from on-site to remote online. By leveraging digital and intelligent technologies， clinical trial institutions can break through development bottlenecks， which not only improves the efficiency of whole-process management in clinical trials to achieve quality improvement and efficiency enhancement， but also lays a foundation for medical institutions to build differentiation， control risks， ensure quality， and enhance core competitiveness. Decentralized clinical trials （DCT）， remote monitoring of clinical trials， and other approaches have become new intelligent and normalized models for clinical trial operation and management. Such applications have reached a certain scale in China， and relevant practical consensus has been continuously issued. To present the advantages of digital intelligence such as "data visualization， risk controllability， and quality verifiability"， and to further provide empirical references and guidance for the implementation and optimization of digital intelligence supervision in remote monitoring of clinical trials in China， this study takes the operational practice of the remote monitoring platform for clinical trials in the Southern Hospital of Southern Medical University as a case. Based on the review of the technical requirements and architecture for the construction of remote monitoring platforms， this study explores the management path of remote monitoring， analyzing the implementation benefits of remote monitoring， including： significantly reducing clinical trial operational costs， effectively optimizing monitoring work hours allocation and time utilization， improving monitoring work quality， and achieving green and low-carbon benefits. This study puts forward relevant suggestions for the problems identified： a complete data tracing chain can be formed by constructing a source data index map， establish unified document naming and classification rules to ensure standardized management of document strengthen the management of the remote monitoring platform through permission control and trajectory monitoring to standardize operation management， with the help of remote monitoring platform to collaborate the quality management of multi-campus public hospitals， to practice a new model of high-quality and efficient clinical trial operation and management.