研究者发起的临床研究风险管理模式探讨  

Preliminary study of risk management mode for investigator-initiated clinical trials

作　　者：谭小燕 林丽玲 唐文韬[1] 岑韬 鲁鸿[2] Tan Xiaoyan;Lin Liling;Tang Wentao;Cen Tao;Lu Hong(Department of Research and Development,Nanfang Hospital,Southern Medical University,Guangzhou 510515,China;General Administration Office,Nanfang Hospital,Southern Medical University,Guangzhou 510515,China)

机构地区：[1]南方医科大学南方医院科研处,广州510515 [2]南方医科大学南方医院院办公室,广州510515

出　　处：《中华医学科研管理杂志》2019年第6期474-478,共5页Chinese Journal of Medical Science Research Management

摘　　要：目的从临床研究管理人员的角度,探讨研究者发起的临床研究(IIT)的风险管理模式,为其在我国的建立与实施提供参考。方法分析我国IIT面临的风险及其风险管理现状;参考国内外风险管理标准或指南,探索适用于我国I1T的风险管理模式。结果提出IIT的风险管理模式,介绍了IIT风险管理的具体框架和流程。结论本文提出的IIT风险管理模式为临床研究管理提供了新的思路。Objective To explore the risk management model of investigator-initiated clinical trials(IITs)from the prospective of clinical research management personnel,to provide further reference for its construction and implementation in China.Methods The risks in IITs and its current situation of risk management were analyzed.Risk management standards including ISO 31000 and related guidelines were adopted to explore the risk management mode for China-based IIT.Results This article proposed the new risk management mode for IITs and also introduced the vSpecified frame and procedures of related risk management.Conclusions The risk management model proposed in this article provided reference for clinical research management.

关 键 词：研究者发起的临床研究 风险管理 风险评估 风险控制 

分 类 号：R197.323[医药卫生—卫生事业管理]