研究者发起的临床研究质量管理体系建设  

The construction of quality management system for investigator-initiated trials

作　　者：张卿 高源[1] 黄轶刚[2] 张长青[2] 张力 ZHANG Qing;GAO Yuan;HUANG Yigang;ZHANG Changqing;ZHANG Li(Clinical Research Center,Tongji Hospital,Tongji University,Shanghai 200065,China;Department of Orthopedics,Shanghai Sixth People’s Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200233,China)

机构地区：[1]同济大学附属同济医院临床研究中心,上海200065 [2]上海交通大学医学院附属第六人民医院骨科,上海200233

出　　处：《上海医药》2024年第5期9-13,76,共6页Shanghai Medical & Pharmaceutical Journal

基　　金：上海市卫生健康委员会卫生健康政策研究课题(2023HP40);上海申康医院发展中心“临床三年行动计划”项目(SHDC2022CRS048、SHDC2023CRS030);上海申康医院发展中心管理研究项目(2023SKMR-30);上海市科学技术委员会“科技创新行动计划”软科学研究项目(23692113100)。

摘　　要：我国研究者发起的临床研究(investigator-initiated trial,IIT)数量持续增加,同时其研究质量问题也逐渐凸显。如何建设和优化医疗卫生机构IIT质量管理体系,提升研究质量,成为医疗卫生机构管理者关注的焦点之一。本文梳理国际/我国质量管理标准,结合IIT质量管理实践,提出应将质量管理的基本原则、要求和方法应用于医疗卫生机构IIT质量管理体系建设。医疗卫生机构管理者须根据IIT的特点建设与IIT相适宜的质量管理体系,以保障受试者的权益和安全,确保研究数据的真实性和可靠性。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.

关 键 词：研究者发起的临床研究 质量管理体系 质量管理标准 

分 类 号：R197[医药卫生—卫生事业管理] R951[医药卫生—公共卫生与预防医学]