王超 刘佳 李洪皎 吕晓颖 魏绪强 何丽云

    摘要 目的：明确真实世界针灸病例注册登记研究质量控制方法应遵循的原则，规范针灸病例注册登记研究质量控制中现场稽查工作，提高针灸病例注册登记研究质量。方法：基于针灸病例注册登记研究稽查工作实践并借鉴其他质控工作的经验总结对稽查环节进行优化。结果：从稽查要点、流程、注意事项出发，形成真实世界针灸病例注册登记研究的现场稽查设计方案。结论：真实世界针灸病例注册登记研究质量控制工作应遵循伦理性、真实性、及时性、可溯源性原则。规范的现场稽查工作是针灸病例注册登记研究质量控制工作的重要环节，也是针灸病例注册登记研究科学性的有力保障。

    关键词 真实世界;针灸;注册登记;质量控制;稽查;监查;伦理;人工智能

    Experience of On-site Inspection in Quality Control of Registered Studies on Acupuncture and Moxibustion Cases in Real World

    WANG Chao1，LIU Jia1，LI Hongjiao1，LYU Xiaoying1，WEI Xuqiang2，HE Liyun1

    ( Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China; 2 Yueyang Hospitals of Integrated Traditional Chinese and Western Medicine，Shanghai University of Traditional Chinese Medicine，Shanghai 200437，China)

    Abstract Objective：To set forth principles for quality control and standardize the quality control of registered studies on acupuncture and moxibustion cases.Methods：The inspection was optimized based on the practice on registered studies on acupuncture and moxibustion cases and the experience of quality control in other aspects.Results：With key points ......