EpiData用于数据管理逻辑核查功能的实现  

Ways of logical check in data management with EpiData

作　　者：郭郡浩[1] 刘玉秀[2] 蔡辉[1] 

机构地区：[1]南京军区南京总医院中西医结合科,南京210002 [2]南京军区南京总医院医务部,江苏

出　　处：《中国临床药理学与治疗学》2008年第5期541-544,共4页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：江苏省"六大人才高峰"第三批资助项目(06-C-031)

摘　　要：目的:探讨借助EpiData软件实现药物临床试验数据管理逻辑核查以保证数据正确性的有效手段。方法:应用EpiData提供的CHECK命令和WRITENOTE命令,产生变量核查法和记录核查法两种逻辑核查方法,对数据库中的数据进行可靠性检验。变量核查法是以数据库中的变量为单位进行逻辑核查,记录核查法是以数据库中的记录为单位进行逻辑核查。结果:两种逻辑核查方法均能核查出逻辑错误的数据,有效地实现了对数据库中数据的逻辑核查。结论:EpiData用于药物临床试验数据的逻辑核查,方法简便、有效、可靠。AIM： To explore the method of logical check in data management in good clinical practice （GCP） with EpiData. METHODS： The two methods of logical check, variable check and recording check were set up through the orders of CHECK and WRITENOTE in EpiData. Validity test on data in database was done. In variable check, the variance was checked as a unit. In recording check, recording in database was done as a unit. RESULTS： The incorrect data would be checked with the above two methods, which can check data in database effectively. CONCLUSION： The function of logical check on data in GCP is a simple, effective and reliable way.

关 键 词：临床试验 数据管理 逻辑核查 EPIDATA 

分 类 号：R311[医药卫生—基础医学]