Risk management in clinical trials of anesthetic agents and products under ICH GCP E6(R3)Guidelines
ZHANG Yiwei
HUA Ye
CHEN Ji
WANG Xin
SHI Lin
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.
Keywords：ICH GCP E6(R3)anesthetic agents and productsclinical trialrisk management
Publication Date：2025-10-15
Online Publishing Date：2025-09-30(First online date of this platform, not the publication date of the document)
Pages：4( 365-368 )