本研究旨在探讨申办者在医疗器械临床试验中构建文件质量控制体系的必要性,并介绍基于量化评价的全面质量控制体系。该体系以国内相关规范为指导,涵盖研究中心和申办者文件夹的质控,通过评分机制客观评估文件质量,并结合质控员–监查员–研究者反馈环路以及质控员–质控体系负责人–质控体系环路,实现问题发现、整改和持续改进。超过85%的临床试验质控评分呈现出逐次上升的趋势,质控中问题的发生率也呈现出下降趋势。该体系有效提升了临床试验文件质量,为申办者提供了标准化、可操作的质控流程,为提升我国医疗器械临床试验整体管理水平提供了参考。This study aims to investigate the necessity for sponsors to establish a quality control system for clinical trial documentation in medical device clinical trials and to introduce a quantitatively assessed total quality control system. Guided by domestic regulations, this system encompasses the quality control of both investigator and sponsor Trial Master File (TMF). TMF quality can be assessed objectively through a scoring mechanism, which is integrated with a feedback loop involving quality controllers, monitors, and investigators, as well as a loop between quality controllers, quality control management, and the quality control system, to facilitate problem identification, rectification, and continuous improvement. Over 85% of clinical trial quality control scores showed a trend of successive increase, and the incidence of issues identified during quality control also demonstrated a decreasing trend. The system effectively enhances the quality of clinical trial documentation, providing sponsors with a standardized and operational quality control process, and serves as a reference for improving the overall management level of medical device clinical trials in our country.
