The course takes you through an example clinical study sample data and generates various clinical study reports that are submitted to the FDA (in the US) or other regulatory authorities in other countries. You will not only hone your SAS programming skills but will also learn essential concepts needed to work in the pharma industry in the areas of biostatistics and clinical data management.
After the introduction to the pharma industry and learning relevant concepts about clinical trials, the course takes you through a hands-on training exercise to build the very important and fundamental clinical study report, called the demographics table.
You will begin with a sample clinical study data in an Excel sheet, then you will import it into SAS, derive all necessary variables as shown in the mock table, and finally, generate a clinical study report. All this will be done using guided SAS programming steps with detailed explanations at every step of the programming.
By the end of this course, you will have learned to work with clinical study data, generate a real clinical study report, and extend those steps to build other reports that constitute clinical trial submissions to the regulatory bodies.
The code files and all related files are added on GitHub at
https://github.com/PacktPublishing/The-Simplest-Guide-to-Clinical-Data-…-
Learn the fundamental concepts of clinical drug development/trials
Understand various phases of clinical trials in the context of SAS programming
Get introduced to the usage of various clinical study documents
Collect, store, analyze, and report data using SAS
Import, prepare, restructure, and visualize data
Generate clinical study reports from the derived data you will create
Please note that basic SAS programming is a requirement to complete this course. No prior pharmaceutical experience is necessary. Internet connectivity is necessary for working in the SAS Studio Edition using SAS OnDemand (no installation required).