医药导报2026，Vol.45Issue(4)：731-734,4.DOI:10.3870/j.issn.1004-0781.2026.04.025
基于检查视角浅析申办者在临床试验中的质量管理
Inspection Perspectives on Sponsors'Quality Management Practices in Clinical Trials
王元 1韩聪凡 1高荣1
作者信息
- 1. 国家药品监督管理局食品药品审核查验中心,北京 100163
- 折叠
摘要
Abstract
As the responsible entity for drug clinical trials,the sponsor's quality management system is directly related to the protection of subjects'rights,the reliability of trial data and the scientific validity of trial outcomes.This paper,based on the current Good Clinical Practice regulations in China and combined with the analysis of inspection practices,systematically analyzed the key points in current clinical trial inspection regarding the sponsor's quality management.Accordingly,this paper discussed the challenges and issues faced by sponsors in quality management,integrating the latest concepts of ICH E6(R3)to outline the development direction of sponsor quality management,with the aim of continuously enhancing the overall quality level of drug clinical trials in China.关键词
药物临床试验/药物临床试验质量管理规范/申办者/质量管理Key words
Drug clinical trials/Good Clinical Practice/Sponsor/Quality management分类
医药卫生引用本文复制引用
王元,韩聪凡,高荣..基于检查视角浅析申办者在临床试验中的质量管理[J].医药导报,2026,45(4):731-734,4.
