The Simplest Guide™ to Clinical Data Analysis with SAS

Overview

In the realm of pharma and life sciences, clinical data analysis is a critical skill that demands precision and expertise. This course breaks down the intricate processes involved in analyzing clinical trial data using SAS, making it accessible to professionals at all levels. You'll begin with an introduction to the industry, understanding the components and phases of clinical trials, and the various types of data and reports involved. The course then guides you through the essential clinical study documents, including the study protocol, informed consent, inclusion-exclusion criteria, and the Statistical Analysis Plan (SAP). By mastering these documents, you'll lay a solid foundation for building comprehensive Clinical Study Reports (CSRs). The hands-on approach of the course ensures that you not only learn the theoretical aspects but also how to apply them practically. As you progress, you'll dive into the detailed steps of programming CSRs using SAS. From understanding case report forms and importing raw data to deriving critical variables like AGE, SEX, and RACE, and finally compiling all the summary statistics, the course walks you through each step with clarity. By the end, you'll have the confidence to produce polished, professional-grade reports, essential for advancing your career in clinical data analysis. This course is designed for data analysts, statisticians, and professionals in the pharma and life sciences industries who want to deepen their understanding of clinical data analysis using SAS. A basic understanding of clinical trials and prior experience with SAS programming is recommended but not required.

Syllabus

Introduction

In this module, we will introduce the foundational aspects of the pharma/life sciences industry, focusing on the clinical trial process. We’ll explore industry components, phases of clinical trials, and the various data types and reports integral to clinical research.

Get to Know the Clinical Study Documents

In this module, we will delve into the essential documents involved in clinical studies. We’ll examine the clinical study protocol, informed consent, inclusion-exclusion criteria, and key analytical documents like the SAP, mock shells, and CRFs.

Building the Clinical Study Reports (CSR)

In this module, we will guide you through the creation of Clinical Study Reports using SAS. We’ll cover the basics of SAS registration, explore programming steps for CSRs, and focus on building demographic tables and deriving key variables such as AGE, SEX, and RACE.