【摘要】 基于江苏省中医院科研数据平台体系,探讨医疗机构中药制剂人用经验临床实践数据的采集流程,梳理数据质量控制与治理要点。通过整合医疗研究电子病历系统、科研数据中心、多中心临床研究数据采集与管理系统,构建一套混合数据采集模式,形成科学、规范、可操作、可复制的数据收集与整理路径。该模式不仅实现了对临床实践数据的系统性采集,为散在的临床实践数据转化为高质量的人用经验证据提供信息化支持,还提供智能化的检索与分析工具。实践表明,该模式借助数字化手段有效实现了人用经验临床实践数据的智能化管理,突破了传统研究中的数据瓶颈,为医疗机构中药制剂的新药临床研发降本增效,并为开展真实世界研究及多中心协作提供了坚实的数据平台支撑。未来需进一步完善中医药数据标注标准化体系,加强医学人工智能复合型人才培养,以推动人用经验信息采集的智能化。更多还原

【Abstract】 Based on the scientific research data platform system of Jiangsu Provincial Hospital of Chinese Medicine, this paper explores the collection process of clinical practice data on human experience of Chinese medicine preparations in medical institutions, and summarizes the key points of data quality control and governance. By integrating the Electronic Medical Record for Research, Research Data Repository and Multi Center Electronic Data Capture System, a hybrid data collection model is constructed to form a scientific, standardized, operable and replicable data collection and organization path. This mode not only achieves systematic collection of clinical practice data, providing information support for the transformation of scattered clinical practice data into high-quality human experience evidence, but also provides intelligent retrieval and analysis tools. Practice has shown that this model effectively achieves intelligent management of human experience clinical practice data through digital means, breaks through the data bottleneck in traditional research, reduces costs and increases efficiency for clinical research and development of new Chinese medicine preparations in medical institutions, and provides a solid data platform support for conducting real-world research and multi center collaboration. In the future, it is necessary to further improve the standardization system of Chinese medicine data annotation, strengthen the training of medical artificial intelligence composite talents, and promote the intelligence of human experience information collection.更多还原