临床试验中偏离方案的管理  

Management of protocol deviation in clinical trials

作　　者：卜擎燕[1] 谢立群[2] 熊宁宁[1] 

机构地区：[1]南京中医药大学附属医院临床药理科,南京210029 [2]南京医科大学第一附属医院,南京210029

出　　处：《中国新药杂志》2012年第18期2121-2125,共5页Chinese Journal of New Drugs

摘　　要：临床试验中偏离方案的情况时有发生,难以避免。作者通过查阅国际相关法规与指南,结合自身的国际多中心临床试验经验,对偏离方案作系统论述,明确其定义、分类和危害,从申办者和临床研究机构/研究者两方面探讨偏离方案预防和发生偏离后的管理。Protocol deviation occurs in clinical trials from time to time, and is difficult to avoid. In this ar ticle, we discussed protocol deviation in a systemic way. The definition of the terminology, its classification and its potential hazard were described. The approaches of prevention and management of occurred protocol deviation should be adopted by sponsor and investigator/institution.

关 键 词：临床试验 偏离方案 违背方案 不依从 

分 类 号：R95[医药卫生—药学]