医疗机构临床试验合同管理常见问题及对策研究  

Research on problems and countermeasures of the management of clinical trials’contracts in medical institutions

作　　者：曹钰然[1] 曹国英[1] 张菁[1] 吴翠云[2] 詹慧中 毛颖[1] CAO Yu-ran;CAO Guo-ying;ZHANG Jing;WU Cui-yun;ZHAN Hui-zhong;MAO Ying(Office of Drug Clinical Trial Institute,Huashan Hospital,Fudan University,Shanghai 200040,China;Institutional Review Board,Huashan Hospital,Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华山医院药物临床试验机构,上海200040 [2]复旦大学附属华山医院伦理审查委员会,上海200040

出　　处：《中国新药杂志》2019年第24期2997-3000,共4页Chinese Journal of New Drugs

摘　　要：目的:加强药物/医疗器械临床试验的合同管理,保证临床试验的合规性。方法:对本院2013年8月-2018年8月期间审核发现问题突出的130份临床试验合同进行回顾梳理,总结归纳临床试验合同及其管理中存在的问题,提出相应的应对策略。结果:应规范管理临床试验合同,保障研究机构/研究者和受试者的合法权益。结论:加强临床试验合同管理,有助于促进临床试验工作的健康、持续发展。Objective:To strengthen the management of clinical trials’contracts of drugs and medical devices and improve the standardization of clinical trials.Methods:Based on analysis of the problems of 130 clinical trials’contracts from Aug 2013 to Aug 2018,corresponding countermeasures were put forward.Results:Scientifically managing clinical trials’contracts could protect the rights and interests of research institutions/researchers and subjects.Conclusion:Strengthening the management of clinical trials’contracts could promote the healthy and sustainable development of clinical trials.

关 键 词：临床试验 合同管理 问题 对策 

分 类 号：R969.4[医药卫生—药理学]