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中国临床药理学与治疗学 ›› 2023, Vol. 28 ›› Issue (1): 51-58.doi: 10.12092/j.issn.1009-2501.2023.01.007

• 临床药理学 • 上一篇    下一篇

医疗器械临床试验质量管理及指标体系研究

戴加惠1,3,孙思嘉1,3,解雪峰1,2,3   

  1. 1安徽医科大学药学院,2安徽省药品监管科学研究中心,3安徽省炎症与免疫性疾病实验室,合肥 230032,安徽 
  • 收稿日期:2022-11-03 修回日期:2023-01-13 出版日期:2023-01-26 发布日期:2023-02-14
  • 通讯作者: 解雪峰,女,博士,教授,研究生导师,研究方向:临床药学和药事管理学。 E-mail: xiexuefeng@ahmu.edu.cn
  • 作者简介:戴加惠,女,硕士研究生,研究方向:临床药学和药事管理学。 E-mail: 1781658328@qq.com
  • 基金资助:
    安徽省高校重大科研项目奖补支持协同创新项目(自然类)(GXXT-2021-068);安徽医科大学科研平台基地建设提升计划(2022xkjT045);安徽省药品上市许可持有人药物警戒工作指南研究(AHYJ-KJ-202208)

Quality management and indicator system for clinical trials of medical devices

DAI Jiahui1,3, SUN Sijia 1,3, XIE Xuefeng1,2,3   

  1. 1 Pharmacy College of Anhui Medical University, 2 Anhui Provincial Drug Regulatory Scientific Research Center, 3 Inflammation and Immune Mediated Diseases Laboratory of Anhui Province, Hefei 230032, Anhui, China
  • Received:2022-11-03 Revised:2023-01-13 Online:2023-01-26 Published:2023-02-14

摘要: 目的:通过对医疗器械临床试验质量管理指标体系的研究,为建立持续改进的医疗器械临床试验质量体系提供有益参考。方法:通过文献调研、专家咨询等方法,总结医疗器械临床试验在质量管理、临床试验数据和临床试验研究人才队伍建设等各个环节中存在的风险,对风险进行分析并提出临床试验质量管理指标体系,以及相应质量改进的措施。结果:建立一个适宜的医疗器械临床试验质量评价管理工具,用以开展质量风险监测和管理,支持和帮助医疗器械临床试验质量管理体系的建设。结论:对临床试验各个环节进行风险识别,初步建立评估指标体系,为临床试验质量管理的效果评价提供参考。

关键词: 医疗器械, 临床试验, 质量管理, 指标体系

Abstract:

AIM: Exploring medical device clinical trial quality management indicator system to continuously improve medical device clinical trial quality system construction. METHODS: Through literature research and Delphi method, we summarized the risks of medical device clinical trials in various aspects such as quality management, clinical trial data, and clinical trial research personnel construction, analyzed the risks and proposed a clinical trial quality management index system, as well as corresponding quality improvement measures. RESULTS: To establish an appropriate medical device clinical trial quality evaluation management tool for quality risk monitoring and management, and to support and help the construction of a medical device clinical trial quality management system. CONCLUSION: To identify risks in various aspects of clinical trials and establish a preliminary assessment index system to provide a reference for the evaluation of the effectiveness of clinical trial quality management.

Key words: medical devices, clinical trials, quality management, indicator system

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