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Validating Clinical Trial Data Reporting with SAS (SAS Press)
Validating Clinical Trial Data Reporting with SAS - SAS Press Author:Brian Shilling, Carol Matthews Validation is a critical component to programming clinical trial analysis. Essential to effective validation is the programmer's understanding of the data with which they'll be working. If you don't understand how the data is arranged, the values that are reasonable for each variable, and the way the data should behave, you cannot ensure that th... more »e final result of your programming effort is complete or even appropriate. Therefore, to be a successful programmer in the pharmaceutical industry, you need to understand validation requirements and to learn how to make the code do the bulk of the work so that your programs are efficient as well as accurate. This indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and output to the Food and Drug Administration (FDA). The authors provide practical examples, explanations for why different techniques are helpful, and tips for avoiding errors in your output. Topics addressed include:
Validation and pharmaceutical industry overviews
Documentation and maintenance requirements discussions
General techniques to facilitate validation
Data importing and exporting
Common data types
Reporting and statistics
This book is designed for SAS programmers who are new to the pharmaceutical industry as well as for those seeking a good foundation for validation in the SAS programming arena. Readers should have a working knowledge of Base SAS and a basic understanding of programming tasks in the pharmaceutical industry.« less