临床试验协议管理常见问题  

Common Problems and Countermeasures of Clinical Trial Agreement

作　　者：刘婧[1] 弭凤玲[2] 赵伟杰[1] 张彤群[3] 初乃惠[1] 蔡超[4] LIU Jing;MI Fengling;ZHAO Weijie;ZHANG Tongqun;CHU Naihui;CAI Chao(Clinical Trial Agency Office, Beijing Chest Hospital, Capital Medical University,Beijing 101149;Department of Technology,Beijing Chest Hospital, Capital Medical University,Beijing 101149;Ethics Committee Office, Beijing Chest Hospital, Capital Medical University,Beijing 101149;Beijing Chest Hospital, Capital Medical University,Beijing 101149)

机构地区：[1]首都医科大学附属北京胸科医院药物临床试验机构办公室,北京101149 [2]首都医科大学附属北京胸科医院科技处,北京101149 [3]首都医科大学附属北京胸科医院伦理委员会,北京101149 [4]首都医科大学附属北京胸科医院,北京101149

出　　处：《解放军医院管理杂志》2018年第2期135-136,159,共3页Hospital Administration Journal of Chinese People's Liberation Army

基　　金：国家科技重大专项:抗结核药物临床评价技术平台建设(2017ZX09304009)

摘　　要：临床试验协议是保障临床试验顺利开展并有效防范风险的重要法律文书,本研究对该院72份临床试验协议进行梳理,总结临床试验协议中协议不完整、权责不明确、语言笼统、违背相关法规和费用无成本核算等常见问题,以及临床试验协议管理中人员法律意识淡薄、部门职责不清、无协议审核标准原则和未实现电子信息化管理等常见问题。提出应通过建立健全临床试验协议管理制度、加强协议规范化建设、建立临床试验成本核算体系、实现临床试验协议电子化管理和加强人才队伍专业化建设等应对策略,高效管理临床试验协议,有效防范合同风险,保障医院合法利益。Clinical trial agreement is an important step to ensure the smooth development of clinical trials and to effectively prevent the risk.The article reviewed and summarized common problems from72clinical trials agreements from Beijing Chest Hospital,and proposed to strengthen institution,organization,standardization,cost accounting system,electronic file system and personal construction of clinical trial agreements.

关 键 词：临床试验协议 协议管理 问题 应对策略 

分 类 号：R197.32[医药卫生—卫生事业管理]