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Improving the quality of data in randomized clinical trials: The compact computer package. Compact steering committee
Author(s) -
Chilvers C. E. D.,
Fayers P. M.,
Freedman L. S.,
Greenwood R. M.,
Machin D.,
Palmer N.,
Westlake A. J.
Publication year - 1988
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.4780071109
Subject(s) - computer science , fortran , completeness (order theory) , consistency (knowledge bases) , protocol (science) , syntax , data file , data mining , database , programming language , artificial intelligence , medicine , mathematical analysis , alternative medicine , mathematics , pathology
Abstract 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.