Data management for toxicological studies.

Organized data management increases the reliability of statistical analysis. The basic purpose of data management is to assure the integrity and the quality of data. To assure data validity, establishing a checking system, such as data audit, would be desirable at the following points: protocol design, supervision of study schedule, definition of data, data collection, choice of tests and procedures, verification, data checking, data recording, data handling, data analysis, and data validation. To process an enormous amount of data on a multitude of items, use of a computerized system would be advantageous. The data processing system in toxicological studies should be based on a protocol-driven system, which gathers and records the data accurately. The main functions that are to be handled by computer are data collection, recording and retrieval via terminals, and statistical analysis of data and assembling of reports. One should be able to validate whether the computer system would perform its intended function accurately, reliably, and consistently. This paper discusses the basic considerations of data management and provides examples of the state of the computerized data management system and its validation.