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临床研究盲态数据核查常用的SAS宏程序
引用本文:薛钧,邹建东,熊宁宁.临床研究盲态数据核查常用的SAS宏程序[J].中国临床药理学与治疗学,2008,13(5):535-540.
作者姓名:薛钧  邹建东  熊宁宁
作者单位:1. 南京中医药大学,南京,210046,江苏;江苏省中医院(南京中医药大学附属医院)国家药物临床试验机构,南京,210029,江苏
2. 江苏省中医院(南京中医药大学附属医院)国家药物临床试验机构,南京,210029,江苏
基金项目:科学技术部科技支撑计划
摘    要:宏程序的使用可以使程序编得更有效和便于维护,在不同的SAS数据步或过程步之间高效传递数据,重复执行SAS程序码,有利于提高数据盲态审核工作的效率和质量。本文主要介绍随机化实施检查的宏程序、各分中心试验起止时间检查的宏程序、数据缺失报告的宏程序、实验室定量指标正异常判断的宏程序,以利于读者了解如何在临床研究中应用SAS宏程序来进行高效的盲态数据核查工作。

关 键 词:临床研究  盲态数据核查  SAS程序

Commonly used SAS macro programs in blind data review of clinical trials
XUE Jun,ZHOU Jian-dong,XIONG Ning-ning.Commonly used SAS macro programs in blind data review of clinical trials[J].Chinese Journal of Clinical Pharmacology and Therapeutics,2008,13(5):535-540.
Authors:XUE Jun  ZHOU Jian-dong  XIONG Ning-ning
Institution:XUE Jun, ZHOU Jian-dong, XIONG Ning-ning( 1Nanjing University of Traditional Chinese Medicine, 2National Clinical Drug Trial Institution, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing 210029, Jiangsu, China)
Abstract:Macromutine is applied to facilitate programming and maintenance in common, to transmit data in different data pace or process pace efficiently, and will profit the efficiency and quality of blind data review of clinical trials. This article introduces several commonly used SAS macro programs including macro programs checking the implementation of randomization, macro programs checking start and terminal time of each clinical trial centers, macro programs reporting missing data, and macro programs judging lab indices in normal range or not, so as to introduce how to use SAS macro programs to facilitate blind data review of clinical trials.
Keywords:clinical trail  blind data review  SAS program
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