The Simplest Guide™ to Clinical Data Analysis with SAS
Video description
This course gives an introduction to the pharmaceutical/life sciences industry in a simple and visual style that is easy to understand. It shows how SAS is used as a tool to work with the vast amount of clinical data within this industry.
About This Video
Dive head-first into the life sciences/pharmaceutical industry
Master concepts of clinical drug development/clinical trials processes
Learn how SAS programming is an …
The Simplest Guide™ to Clinical Data Analysis with SAS
Video description
This course gives an introduction to the pharmaceutical/life sciences industry in a simple and visual style that is easy to understand. It shows how SAS is used as a tool to work with the vast amount of clinical data within this industry.
About This Video
Dive head-first into the life sciences/pharmaceutical industry
Master concepts of clinical drug development/clinical trials processes
Learn how SAS programming is an integral part of putting a drug into the market
In Detail
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.
Audience
Anyone who wants to take up a job as a clinical SAS programmer in a pharma company will find this course useful. Individuals who want to just play with data using the SAS programming concepts and want to take up a job as a clinical SAS programmer in a pharma company or a CRO will also benefit from this course.
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).
Chapter 2 : Get to Know the Clinical Study Documents
Section Overview
The Clinical Study Protocol
The Informed Consent
The Inclusion-Exclusion Criteria
The Statistical Analysis Plan (SAP), Mock Shells, and Case Report Forms (CRFs)
Section Conclusion
Chapter 3 : Building the Clinical Study Reports (CSR)
Section Overview
SAS OnDemand Registration
Logging-In to SAS After Registration
General SAS Programming Steps to Build Any CSRs
Understanding the Demographics Case Report Form (CRF)
Understanding the Demographics Table
Planning to Program the Demographics Table
Importing Raw Demographics Data into SAS
Deciding Which PROCs to Use
Deriving the AGE Variable
Obtaining Summary Statistics for AGE
Adding the Third Treatment Group Using Explicit Output
Deriving the SEX Variable
Obtaining Summary Statistics for SEX
Concatenating the COUNT and PERCENT Variables
Deriving the RACE Variable
Obtaining Summary Statistics for RACE
Stacking All Three Summary Statistics Together
Fixing the Precision Points
Transposing Data
Fixing the Order of Statistical Parameters
Building the Final Report
Putting the Finishing Touches to the Report
Section Conclusion
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