DM03
Techniques for the Successful Management of Laboratory Data for Clinical Research and Development
Benjamin Hampton Frierson, PRA International

During a clinical trial, the results of laboratory tests remain some of the most important indicators of drug safety. It is therefore imperative that a SAS programmer managing these data for safety evaluations command the knowledge of the diverse sources, compilation, formatting, and validation necessary to their reporting in a timely and accurate fashion. This paper will explore and offer solutions to the common challenges faced during the handling of these data: recognizing sources as local, central , or a combination of both to build encapsulated macro code for combining and formatting; ascertaining assorted styles of data transfer for uploading to SAS; enacting edit specifications to subset questionable data for clinical review; compiling and integr ating multiple sets of laboratory reference ranges; and dimensionally aligning test results across sources to form a meaningful comparison with reference ranges as well as to create a uniform presentation of the results for analysis.