| 戴国华,张伯礼,郭治昕,商洪才,张俊华,姚晨,文天才,赵敏,张军平.中心随机化系统在“芪参益气滴丸对心肌梗死二级预防的临床试验研究”项目中的应用[J].,2007,(7):653-656 |
| 中心随机化系统在“芪参益气滴丸对心肌梗死二级预防的临床试验研究”项目中的应用 |
| Application of Central Randomized System in Project of Clinical Trial for Secondary Prevention of Myocardial Infarction by Qishen Yiqi Drop Pill |
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| DOI： |
| 中文关键词: 中心随机化系统 操作要点 芪参益气滴丸对心肌梗死二级预防的临床试验 |
| 英文关键词:central randomization system key operational points clinical trial for secondary prevention of myocardial infarction by Shenqi Yiqi Drop Pill |
| 基金项目:国家科技攻关计划项目(No.2004BA716B01) |
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| 中文摘要: |
| 中心随机化系统实际上是临床试验实施过程中的管理系统,不但可以减少随机化过程中的人为参与,更好地避免偏倚,而且对于用药量大、研究周期较长的大规模临床试验的药品管理尤为重要。本文介绍了中心随机化系统的两个主要功能(即受试者随机化和药品管理),以及临床研究语音应答系统(CRIVRS)在芪参益气滴丸对心肌梗死二级预防的临床试验研究(MISPS-TCM)项目实施过程中的操作要点和注意事项。 |
| 英文摘要: |
| Central randomized system(CRS)is actually a management system for actualizing process of clinical trial,which can not only reduce the factitious jamming during randomization to avoid bias,but also play an important role in drug supervision during long-term and large-scale clinical trials in which a large amount of drugs are applied.This article introduced the two main functions of the CRS,i.e.the randomization of testees and the management of drugs,as well as the key points and instructions for applying clinical research interactive voice responding system(CRIVRS)in operating the project of clinical trial for secondary prevention of myocardial infarction by Shenqi Yiqi Drop Pill. |
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