Ⅰ期临床试验中对受试者安全保障的认识和实践  

Practice of Insuring the Safety of Subjects in the Phase Ⅰ Clinical Trail

作　　者：钱薇[1] 周志群[1] 耿燕[1] 肖大伟[1] 

机构地区：[1]南京大学医学院附属鼓楼医院Ⅰ期临床试验研究室,南京210008

出　　处：《药学与临床研究》2011年第6期561-564,共4页Pharmaceutical and Clinical Research

摘　　要：Ⅰ期临床试验必须遵循《赫尔辛基宣言》和《药物临床试验质量管理规范》(GCP),试验前充分评估受试者(预期和非预期的)风险,试验中严格遵守试验方案和标准操作规程(SOP),保障受试者的安全。Each phase I clinical trail should abide by the Declaration of Helsinki and the Practice of Good Clinical Trial,the investigator must assess risk before the trial and comply with the protocol and SOPs throughout the trial,ensure that subjects who take part in a phase I clinical trail are adequately protected against any possible risks.

关 键 词：I期临床试验 受试者 GCP 

分 类 号：R969[医药卫生—药理学]