Clinical Trials

Biography

Biography: Ballari Sen

Abstract

Efficiently handling Clinical Trial Data based on the Clinical Data Interchange Standards Consortium(CDISC) standard,the regulatory rules from U.S. Food and Drug Administration (FDA) and electronic data submission requirements is very important for Drug Development.

The laboratory dataset is one of the core safety datasets and converting the incoming lab data into a submission–ready format is often challenging and stressful to the programmer. Laboratory data usually come from central laboratories and/or many different local laboratories. Different laboratories usually have different original reported laboratory test names, units and reference ranges. In order to pool and analyze these reported data efficiently and correctly, central/local laboratory test names, units and results must be converted to a standard format.

Thus any work we do for lab data can easily get long and tedious unless we can find a way to standardize or macrotize it.Further, SAS Macros presents a conceptual programming code to maximize the efficiency and avoid tedious repetitive tasks by creating a set of SDTM generation macros and providing all the required study specific information via the SAS co`de.

This poster presentation, focuses on one of the common lab analysis needs – converting lab test results from one unit into another. I begin by describing why it is necessary to perform unit conversions. I then describe some purely SAS - based approaches, since, as SAS programmers, this is typically how we tackle a project. Finally, I explore processes that make use of  SAS Macros,to convert the clinical Lab data to standard format of Standard data tabulation model.