某县级医院建设药物临床试验机构工作实践与思考  

Practice and Experience on the Construction of a Drug Clinical Trial Institu-tion in the County-Level Hospitals

作　　者：谭晓勇 幸勇[1] 李洪勤[1] 张勇[1] 冉启军 苏飞[1] TAN Xiao-yong;XING Yong;LI Hong-qin;ZHANG Yong;RAN Qi-jun;SU Fei(Xuanhan County People's Hospital, Dazhou, Sichuan Province, 635000 China)

机构地区：[1]四川省宣汉县人民医院

出　　处：《中国卫生产业》2019年第14期24-26,29,共4页China Health Industry

摘　　要：目的探讨县级医院建设药物临床试验机构的可行性,为我国县级医院筹建药物临床试验机构提供参考。方法以国家食品药品监督管理局2003年颁布的《药物临床试验质量管理规范》(Good clinical Practice,GCP)及2004年颁布的《药物临床试验机构资格认定办法(试行)》为指导,从组织框架结构搭建、软件建设、硬件建设等几方面总结该院筹建药物临床试验机构的具体实践经过及体会。结果该院领导高度重视,软、硬件设施设备齐全,具备筹建药物临床试验机构的实力。结论县级医院只有充分利用本院优势资源,不断提高全院医务人员对临床试验的认识,按照相关法律法规的规定积极筹备,才能顺利建成药物临床试验机构。Objective To explore the feasibility of construct the drug clinical trial institutions in County-level hospitals, and to provide a reference for the other county-level hospitals in China. Methods This paper summarizes the experience on the preparation of constructing the clinical drug trial institutions in our hospital from the aspects of building of institution,software and hardware construction and so on, guided by the Good Clinical Practice(GCP) promulgated in 2003 and the Qualification Approach for Drug Clinical Trial Institutions(Trial Implementation) promulgated in 2004 by the State Food and Drug Administration. Results Our hospital has the ability to construct drug clinical trial institutions. Conclusion Only taking full advantage of the superior resources,improving constantly medical personnel's understanding to clinical trials,and preparing actively in accordance with relevant laws and regulations, can the country-level hospitals construct the drug clinical trial organization successfully.

关 键 词：县级医院 药物临床试验 药物临床试验质量管理规范 药物临床试验机构建设 

分 类 号：R19[医药卫生—卫生事业管理]