目的:梳理既往接受国家药品监督管理局食品药品审核查验中心(Center for Food and Drug Inspection of NMPA,CFDI)临床试验数据的现场核查情况,分析和探讨2020版《药物临床试验质量管理规范》(Good Clinic Practice, GCP)实施后,药物临...目的:梳理既往接受国家药品监督管理局食品药品审核查验中心(Center for Food and Drug Inspection of NMPA,CFDI)临床试验数据的现场核查情况,分析和探讨2020版《药物临床试验质量管理规范》(Good Clinic Practice, GCP)实施后,药物临床试验数据现场核查常见问题的关注点及要求,以期为临床试验的实施和管理提供参考。方法:收集本院自2015年7月22日以来接受CFDI数据现场核查的不合格情况,共计21个项目接受临床试验核查,不合格项135条。针对既往不合格项中的常见问题,分析2020版GCP和现场核查的关注点及要求。结果:既往不合格项主要集中在过程记录及检查检验数据溯源、方案执行、安全性事件记录、试验用药品的管理与记录、生物样品流通管理、相关数据链的完整性等方面。2020版GCP与现场核查要点对于临床试验数据现场核查常见问题与既往要求有较大差异。结论:在新形势下,需改变既往观念和规则,根据2020版GCP和药物临床试验数据现场核查的关注点及要求开展药物临床试验。展开更多
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...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.展开更多
文摘目的:梳理既往接受国家药品监督管理局食品药品审核查验中心(Center for Food and Drug Inspection of NMPA,CFDI)临床试验数据的现场核查情况,分析和探讨2020版《药物临床试验质量管理规范》(Good Clinic Practice, GCP)实施后,药物临床试验数据现场核查常见问题的关注点及要求,以期为临床试验的实施和管理提供参考。方法:收集本院自2015年7月22日以来接受CFDI数据现场核查的不合格情况,共计21个项目接受临床试验核查,不合格项135条。针对既往不合格项中的常见问题,分析2020版GCP和现场核查的关注点及要求。结果:既往不合格项主要集中在过程记录及检查检验数据溯源、方案执行、安全性事件记录、试验用药品的管理与记录、生物样品流通管理、相关数据链的完整性等方面。2020版GCP与现场核查要点对于临床试验数据现场核查常见问题与既往要求有较大差异。结论:在新形势下,需改变既往观念和规则,根据2020版GCP和药物临床试验数据现场核查的关注点及要求开展药物临床试验。
文摘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.
