Abstract
The article looks at laboratory data from a statistician's point of view, discussing the presentation of the data for individual study reports and then for an integrated safety summary. It covers the benefits of a central laboratory and the difficulties that arise when one is not used. A central laboratory ensures that there is a single unit of measurement for each parameter within a study so that the individual report is much easier to produce. Currently, the conversion of units problem still remains for integrated safety summaries for reports to the Food and Drug Administration (FDA), since standard international (SI) units are not widely used in the United States.
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