GCP在指导临床试验实践中的应用策略  

Application Strategy of Good Clinical Practice for Guiding Cinical Trial Practice

作　　者：杨菁菁[1] 濮之晨 卢建平[1] YANG Jing-jing;PU Zhi-chen;LU Jian-ping(Drug Evaluation Center,Yijishan Hospital,Wannan Medical College,Wuhu 241001,Anhui,China)

机构地区：[1]皖南医学院弋矶山医院药物评价中心,芜湖安徽241001

出　　处：《医学信息》2020年第7期33-35,39,共4页Journal of Medical Information

基　　金：国家自然科学基金(编号:81173134)。

摘　　要：药物临床试验质量管理规范(GCP)对临床试验的操作提出了全流程基本技术要求,主要用于设计、实施、记录、评价和报告临床试验,参与临床试验的各方都有责任按照GCP原则和规定进行研究。申办者、研究中心及研究者团队都应根据规范,遵守基本安全性、准确性和可靠性的规则。我国GCP正处于迅速发展阶段,研究者、申办者、合同研究组织等需要积累丰富的实际应用经验。本文主要对GCP在指导临床试验实践过程中存在的一些问题进行综述,并就其应用策略进行讨论。Good clinical practice(GCP)puts forward the basic technical requirements for the operation of clinical trials,mainly used to design,implement,record,evaluate and report of clinical trials,all parties involved in clinical trials have the responsibility to conduct research in accordance with GCP rules and regulations.Sponsors,research center and team of researchers should follow the rules of basic safety,accuracy and reliability fairly according to the specifications.GCP is at the stage of development,researchers,sponsors,contract research organizations need to accumulate a wealth of practical experience.This article reviews some problems of GCP in guiding clinical trial practice,and discuss the application strategy.

关 键 词：药物临床试验质量管理规范 临床试验 项目管理 

分 类 号：R95[医药卫生—药学]