Abstract
Manual tabulation of findings from the many thousands of tissue samples which have to be examined in modern safety evaluation studies is tedious, time consuming, and subject to the introduction of error.
Computerized systems that are intended to support the pathology application area must provide a flexible mechanism for the direct entry of tissue sample data and produce reports in the format required by legislative authorities. These systems must be able to adapt to the changing requirements for auditing pathology data. Because it is important that these systems work correctly, the relative ease by which they can be validated is also very important.
There are many different approaches for handling pathology data. A system based on a coded dictionary of terms will be discussed. Features of this type of system include ease of data entry, consistency of terminology, standardization of reporting across studies and potential access to companion/complementary systems (eg, interactive video disks). A “parameterized” system means that the system can be customized for the user, by the user, while the base system remains the same, resulting in a system that gives more control to the user and is easier to support.
The benefits of time savings, reduced effort, and greater awareness of trends in the data are offered to pathologists using a computerized system for their application area.
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