ISO9001质量管理标准在药物临床试验机构建设中的应用  

Application of ISO9001 Quality Management Standards in the Construction of Clinical Drug Trial Institution

作　　者：黄泽泓[1] 陈慎仁[1] 庄明华[1] 林萍[1] 

机构地区：[1]广东汕头大学医学院附属第二医院,汕头市515041

出　　处：《中国药房》2005年第14期1115-1116,共2页China Pharmacy

摘　　要：目的:保证药物临床试验的质量和保障受试者的权益。方法:将ISO9001质量管理标准的基本原则、程序和方法,贯穿于我院国家药物临床试验机构的建设中。结果与结论:以ISO9001质量管理体系为铺垫,进行药物临床试验机构的建设,符合《药物临床试验质量管理规范》的要求,有利于保证药物临床试验的质量和保障受试者的权益。OBJECTIVE:To guarantee the quality of the clinical drug trial and to ensure the interests of the subjects.ME- THODS:The basic principles,procedures and methods of ISO9001quality management standards were applied in the whole construction of clinical drug trial institution.RESULTS&CONCLUSION:The construction of clinical drug trial institution based on the ISO9001quality management standards was in conformity with the principle of Good Clinical Practice,which was helpful for the guarantee of the quality of clinical drug trial and the interests the subjects.

关 键 词：ISO9001质量管理标准 药物临床试验 机构建设 

分 类 号：R95[医药卫生—药学]