摘要
目的:探讨临床试验CRF表-全息数据库-统计批处理"联姻"模式。方法:按纸版CRF表建立电子CRF表,并加载库操作程序和近10个常用统计模块,进而构成全息数据库。结果:以上海某大型临床试验资料作为本数据库试验运行之素材,共处理数据元约11万个,做出统计判断约1000份,调用统计工具8种,转换数据类型约10余次,运行时间仅半小时,出具大型试验综合性报告2份,统计归纳报告20余份。结论:此举既可作为电子数据获取系统EDC的应用过渡,也是EDC全面推广的前期实践。
Objective: To explore a holographic database of clinical trial case report forms(CRFs) combined with the function of statistical batch process.Methods: Based on the hard copy of clinical trial CRFs,we establish the electric version of CRFs,then design database operation procedures and nearly 10 common statistic modules,which build up a comprehensive holographic database.Results: To verify the efficiency of the holographic database,we processed the materials from the large-scale clinical trial in Shanghai.During the test,nearly 110,000 data elements were processed and 1000 statistical judgements were made by 8 types of statictial tools and nearly 10 times of data-type conversion.As a result,2 pieces of comprehensive large-scale trial reports and more than 20 pieces of statistical reports were concluded within only half an hour.Conclusions: This study is considered as preliminary application and transitional practice of Electronic data capture(EDC) system.
出处
《数理医药学杂志》
2010年第6期703-708,共6页
Journal of Mathematical Medicine
关键词
临床试验
CRF表
数据库
clinical trial
case report form(CRF)
database