摘要
过程与结果的科学性和可靠性的保证是药物临床试验质量控制的重点和难点。本文主要从试验设计、运行管理以及总结等方面对药物临床试验质量控制存在的问题进行了分析和探讨。
Assured Clinical truial's courses and results scientific and reliabce is very important and dif icult in clinical trial quality control.This paper mainly analyzes and discusses the quality control problems form aspects such as clinical trial design,management of opration,conclusions etc.
作者
郭智
GUO Zhi(Inner Mongolia Medical University Affiliated Hospital Drug Clinical Trial Institution,Huhhot,Inner Mongolia 010050,China)
关键词
药物临床试验
运行管理
质量控制
Clinical drug trial
Management of opration
Quality control
