The number of investigator-initiated trial(IIT)has increased continuously in our country and meanwhile the quality of their studies is gradually becoming prominent.How to construct and optimize quality management system(QMS)of IIT and improve IIT quality has become one of the focuses of managers in the medical and health institutions.This article sorts out international and domestic quality management standards including principles,requirements and methods,analyzes the application in the IIT-QMS construction,and proposes applicability,reference significance and specificity of the quality management standards for IIT-QMS construction.These standards would guide medical and health institutions to construct the effective QMS in order to ensure the rights and safety of subjects and the authenticity and reliability of research data.
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