Validating Clinical Trial Data Reporting with SAS (SAS Press)

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9781599941288: Validating Clinical Trial Data Reporting with SAS (SAS Press)
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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.

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About the Author:

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.

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).

Review:

"This book fills a niche - it is difficult to find specific guidance on programming validation. Often, what can be found is very complicated and not directly applicable to SAS programming in the pharmaceutical industry. Carol and Brian have consolidated a lot of information about clinical trial data report validation and presented it in a way that makes it accessible and usable by programmers at all levels.

This book provides a straightforward, concrete plan for meeting the complex validation requirements that clinical trial data reporting must adhere to. By including actual sample validation checklists in the book's appendix, the authors have allowed readers to implement the suggestions in the book with just a little effort." --Kim Truett, KCT Data, Inc.

"Having taught a pharmaceutical-focused SAS programming class since 1998 using two other SAS Press publications, I am thrilled to say that this book will be such a benefit to my class as well as to others in the industry. The information it contains is 100% applicable to the tasks associated with clinical trial reporting. I recommend this book to SAS programmers just entering the pharmaceutical industry, as well as to those that have years of experience in the industry. There are some wonderful nuggets in this book!" --Daphne Ewing, Sr. Director, Programming, Auxilium Pharmaceuticals, Inc

"For programmers who are relatively new to the industry or for those who have long been part of it, Carol and Brian's book provides a good overview, practical hands-on tips, and many examples of how to perform a thorough validation. The authors' written style allows the reader to almost see and hear Carol and Brian sitting nearby in conversation.

The SAS programming examples in the book are very clear and easy to follow. This is a good reference book for all statistical and clinical SAS programmers." --Susan Fehrer, President, BioClin, Inc.

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Book Description SAS Publishing, United States, 2008. Paperback. Condition: New. Language: English . Brand New Book ***** Print on Demand *****.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. Seller Inventory # AAV9781599941288

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Book Description SAS Publishing, United States, 2008. Paperback. Condition: New. Language: English . Brand New Book ***** Print on Demand *****. 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. Seller Inventory # AAV9781599941288

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Book Description SAS Institute. Paperback. Condition: New. 228 pages. Dimensions: 8.8in. x 7.5in. x 0.8in.Validation is a critical component to programming clinical trial analysis. Essential to effective validation is the programmers understanding of the data with which theyll be working. If you dont 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. This item ships from multiple locations. Your book may arrive from Roseburg,OR, La Vergne,TN. Perfect Paperback. Seller Inventory # 9781599941288

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