dating one2one - Validating clinical trial data reporting

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 (Pharma SUG).

The author also teaches the "SAS Programming Certificate for the Pharmaceutical Industry" course for Philadelphia University's continuing education program.

validating clinical trial data reporting-24

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.

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.

SAS Products and Releases: Base SAS: 9.2, 9.1.3, 9.1.2, 9.1, 9.0 SAS/STAT: 9.2, 9.1.3, 9.1.2, 9.1, 9.0 Operating Systems: All Carol I.

Matthews is Senior Director of Clinical Programming at United Bio Source Corporation (UBC), where she mentors management-level programming staff.

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.

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.

He has over two decades of experience in the pharmaceutical industry and is a chair emeritus of the Pharmaceutical Industry SAS Users Group (Pharma SUG).

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