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Establishing Consistent Programming for Pharmaceutical Safety Summarizations Using a DOW Loop

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Executive Summary

Three types of data collected during an early stage clinical trial study to assess safety are laboratory tests, electrocardiogram parameters, and vital signs. Simple summary statistics of the results and change from baseline are usually presented in an ICH summary report, and it is also useful to include a presentation of out of range shifts relative to baseline. When several varieties of standard programs are available to facilitate summaries, a consistent approach across all datasets and types of summaries in a study could increase efficiency and minimize the possibility of multiple errors. This paper will illustrate an approach that may be applied to various types of data regardless of vertical or horizontal structure.

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