Chilvers C E, Fayers P M, Freedman L S, Greenwood R M, Machin D, Palmer N, Westlake A J
Section of Epidemiology, Institute of Cancer Research, Sutton, Surrey, U.K.
Stat Med. 1988 Nov;7(11):1165-70. doi: 10.1002/sim.4780071109.
One crucial component for a successful clinical trial is that the data gathered have a high level of reliability and completeness. This paper reviews some problems of data management and describes the computer package COMPACT which has been developed to deal with such problems. The package allows range and consistency checks and can monitor complex follow-up schedules. A unique feature of the package is a PROBLEMS file which has use both for identification of queries about the data and of patients with particular characteristics of interest. The ability to monitor drug dosages and to signal deviations from the protocol is of particular value. COMPACT has the syntax necessary to create a 'flat' file for transfer to statistical packages for analysis, and the variable description files for SAS, SPSS and MINITAB. The package is written in standard FORTRAN which enables transfer to different types of mini and micro computer systems.
成功进行临床试验的一个关键要素是所收集的数据具有高度的可靠性和完整性。本文回顾了数据管理的一些问题，并描述了为处理此类问题而开发的计算机程序包COMPACT。该程序包允许进行范围和一致性检查，并能监控复杂的随访计划。该程序包的一个独特功能是“问题”文件，它既用于识别有关数据的疑问，也用于识别具有特定感兴趣特征的患者。监控药物剂量并标记与方案的偏差的能力具有特殊价值。COMPACT具有创建“平面”文件以传输到统计软件包进行分析所需的语法，以及用于SAS、SPSS和MINITAB的变量描述文件。该程序包用标准FORTRAN编写，这使得它能够转移到不同类型的小型和微型计算机系统。
