An Introduction to Creating Standardized Clinical Trial Data with SAS

Chapter 1: Understanding the Industry

In the pharmaceutical industry, there is a mandate to create standardized clinical data using very specific rules. These rules are created and governed by the Clinical Data Interchange Standards Consortium (CDISC). In this book, we describe and illustrate how to create these required CDISC data sets with SAS code. A statistical programmer should be familiar with the CDISC rules required to create standardized clinical trial data sets. After reading this book, readers will be able to understand CDISC standardized clinical data structures, as well as how to create it.

1.1 Statistical Programmer Work Process

In the pharmaceutical industry, the primary goal of a statistical programmer is to create standard data ...