临床试验CRF表-全息数据库-统计批处理“联姻”模式初报

The Clinical Trial Holographic Database of CRFs with Statistical Batch Process

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.