麻醉安全与质控2025，Vol.7Issue(5)：365-368,4.DOI:10.3969/j.issn.2096-2681.2025.05.001
基于新版ICH GCP E6(R3)标准下的麻醉用药(品)临床试验风险管理
Risk management in clinical trials of anesthetic agents and products under ICH GCP E6(R3)Guidelines
张翌韦 1华烨 1陈迹 1王欣 1史琳2
作者信息
- 1. 新疆医科大学第一附属医院药学部,新疆 乌鲁木齐 830000
- 2. 重庆金凤实验室成果转化中心,重庆 401329
- 折叠
摘要
Abstract
This article examines risk management in clinical trials of anesthetic agents and products,aligned with the ICH GCP E6(R3)Guidelines.By analyzing risk characteristics specific to clinical trials of anesthetic agents and products,it outlines key risk management considerations across trial design,trial implementation,data governance and other related aspects.Emphasis is placed on the application of risk-based quality management approaches to enhance the quality of clinical trials,ensure participants'safety,and provide insights for related research.关键词
新版ICH GCP E6(R3)/麻醉用药(品)/临床试验/风险管理Key words
ICH GCP E6(R3)/anesthetic agents and products/clinical trial/risk management引用本文复制引用
张翌韦,华烨,陈迹,王欣,史琳..基于新版ICH GCP E6(R3)标准下的麻醉用药(品)临床试验风险管理[J].麻醉安全与质控,2025,7(5):365-368,4.
