中国药业2026，Vol.35Issue(2)：45-49,5.DOI:10.3969/j.issn.1006-4931.2026.02.009
基于HACCP理论的临床试验质量控制体系探索
Exploration of A Clinical Trial Quality Control System Based on HACCP Theory
摘要
Abstract
Objective To further optimize the clinical trial quality control system.Methods Based on the hazard analysis and Critical Control Point(HACCP)theory,a team was established.After discussion,the key points of the quality management system were preliminarily identified,and two rounds of Delphi method were conducted to clarify the scope,objectives,and progress of HACCP.The team discussion summarized six processes for clinical trial quality management,and critical control points(CCPs)in the clinical trial management process were identified through hazard analysis(HA),and a closed-loop management path for clinical trials was explored.Results Nine CCPs in the clinical trial management process were identified,and mechanisms for pre-event prevention,in-event monitoring,and post-event intervention were established accordingly.By formulating monitoring requirements,corrective measures,and verification procedures for CCPs,a closed-loop management for clinical trials was achieved.Conclusion This study established a prevention-oriented clinical trial quality control system,which can partly prevent and reduce the occurrence of clinical trial quality control incidents,and is of great significance for improving the quality and standardization of clinical trials.关键词
临床试验/质量控制/危害分析与关键控制点/药事管理Key words
clinical trial/quality control/HACCP/pharmaceutical administration分类
医药卫生引用本文复制引用
钱春艳,李洁,杨能,方莉,程海霞..基于HACCP理论的临床试验质量控制体系探索[J].中国药业,2026,35(2):45-49,5.基金项目
江苏省医院协会医院管理创新研究课题面上项目[JSYGY-3-2021-664] （）
江苏省常州市第七批科技计划项目[CJ20242030] （）
江苏省药学会-奥赛康医院药学科研基金重点项目[A202403]. （）
