临床试验协议医院审核与管理  

Hospital Review and Management of Clinical Trial Agreement

作　　者：刘婧[1] 弭凤玲[1] 赵伟杰[1] 张彤群[1] 初乃惠[1] 蔡超[1] 

机构地区：[1]首都医科大学附属北京胸科医院/北京结核病胸部肿瘤研究所药物临床试验机构办公室,北京101149

出　　处：《继续医学教育》2017年第5期86-88,共3页Continuing Medical Education

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环节,对我院临床试验协议管理中常见问题进行了总结,归纳出"签署医疗机构-CRO协议的风险、赔偿、保险、生物样本、终止试验、争议事项处理"6个主要条款常见问题,并提出了针对各个问题的管理措施。通过总结以上问题,规范了医疗机构临床试验协议管理重点及流程,提高了协议管理的质量和效率。Clinical trial agreement is an important step to ensure the smooth development of clinical trials and to effectively prevent the risk. The research summarized common problems of clinical trials agreements management in Beijing Chest Hospital, such as parties, indemnification, insurance, biological sample, termination, dispute resolution problems. The article puts forward to solution problems to the above problems. The article focuses on priorities and processes of clinical trials agreements management, and improves the quality and efficiency of clinical trials agreements management.

关 键 词：临床试验协议 协议管理 医院管理 

分 类 号：R197.3[医药卫生—卫生事业管理]