A SAS Based System for Reporting Laboratory Data from Clinical Trials

A SAS-based laboratory data processing system has been developed to provide reports including patient profiles, abnormality incidences and distribution, safety data summaries, and data edits. Patient profiles display lab data across time with relevant dosing, demographic, concomitant disease and therapy information. Incidence and distribution tables summarize the occurrence of lab abnormalities by drug treatment while safety data summaries provide box plots, bar charts and listings by visit for individual parameters. Data edits allow identification of outliers, errors and missing data. Clinical monitors and data management personnel use these reports for review of on going drug trials. The system has well defined input-interfaces, and is used with data from a variety of laboratories and clinical data processing systems.