Risk-based quality management system in clinical trail
SU Xian
CUI Meng-xun
Abstract：On the basis of ICH related guidline, this paper analyzes the purpose of risk-based quality management system, summarizes s elements to implement it, and discuss the currently issues to opreation. Be acknowleged by international registration and drug research and development, risk-based quality management system will improve the quality of China's clinical trail, CFDA is gradually implementing regulatory laws and related technical guidances.
Keywords：risk-based quality managementclinical trailGCP
Publication Date：2018-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 1721-1725 )