摘要
目的:为药物临床试验机构和监管部门对试验药品的管理和监管提供参考。方法:针对目前药物临床试验中试验药物管理存在的各种问题,进行归纳,并提出应对措施。结果与结论:试验药物管理的诸多问题存在于临床试验中的各个环节,各机构应建立并逐步完善严格规范的药物管理制度,积极借鉴信息化管理等新技术和方法,加强GCP培训。
OBJECTIVE： To provide reference for drug management and monitoring in drug clinical trial institutions and monitoring authorities. METHODS： Various problems faced by authorities and institutions were summarized to put forward regulatory measures. RESULTSCONCLUSIONS： There are many problems of drug management in clinical trails. The strict and standardized management system should be established in every institution, especially the new control skills such as IT, and GCP training should be strengthened.
出处
《中国药房》
CAS
CSCD
北大核心
2011年第22期2093-2094,共2页
China Pharmacy
关键词
临床试验
药品管理
问题
对策
Clinical trials
Drug management
Problems
Solutions
