Development of the System which Enables Dynamic Data Check Regardless of EDC Systems Type

Abstract

　In clinical studies, data management is very important for ensuring the data quality and adequate statistical analyses. When performing a data check, either a sight check using human eyes or a logical check using a computer is carried out. In recent years, electronic data capture (EDC) systems having been used to assess the data consistency or to check for missing data at the same time as data entry; however, this check method is not sufficient. Therefore, data managers are required to check the data files exported from EDC systems. However, most clinical data managers are medical experts without advanced programming skills at academic data coordinating centers. The objective of this study was to develop a versatile software program with a graphical user interface to help data managers clean up data easily and efficiently for clinical research. In order to achieve versatility, the program needed to be able to unify the data structure, merge multiple files, and automatically create a specifications check file. We applied the developed software program to two different types of clinical trials and verified its function and effectiveness. Compared with a sight check, our program was thus found to be cost-efficient in terms of time and labor.