the author made a summary about clinical trial management and quality control of clinical drug trial based on the hospitals practice in recent years.
近年来,本院逐步认识到加强药物临床试验的管理,完善质控的重要性。
this issue introduces the existing problems and corresponding countermeasure about the compensation to the subjects impairment in chinese clinical drug trial nowadays.
本文介绍我国目前药物临床试验中受试者损害补偿存在的问题和对策。
me- thods:the basic principles, procedures and methods of iso9001quality management standards were applied in the whole construction of clinical drug trial institution.
方法:将iso9001质量管理标準的基本原则、程序和方法,贯穿于我院国家药物临床试验机构的建设中。
statistical analysis is an important step in clinical drug trial and standard statistical analysis can reveal the true characteristics of drugs.
统计分析是药物临床试验整个过程中的一个重要环节,规范化的统计分析能真实地揭示药物的性能。