Validating Clinical Trial Data Reporting with SAS

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 the 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). Authors Carol Matthews and Brian Shilling 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

Validating Clinical Trial Data Reporting with SAS 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.

Carol I. Matthews: Carol I. Matthews is Senior Director of Clinical Programming at United BioSource Corporation (UBC), where she mentors management-level programming staff. She develops, documents, and maintains a centralized macro library and is responsible for the migration of SAS software. A SAS user since 1990, Carol is a frequent presenter at the Pharmaceutical Industry SAS Users Group (PharmaSUG). Brian C. Shilling: Brian C. Shilling is Senior Manager of Clinical Programming at United BioSource Corporation (UBC), where he manages a team of SAS programmers. He has over two decades of experience in the pharmaceutical industry and is a chair emeritus of the Pharmaceutical Industry SAS Users Group (PharmaSUG). Brian is an adjunct faculty member at Philadelphia University and Arcadia University in Philadelphia, PA.