A delightful introduction to the field of clinical data validation and reporting! Concepts and techniques are gently presented with hands-on examples and accompanying SAS code. The reader will appreciate the comprehensive review of important terminology such as CRF, eCTD, CDISC, ADaM, SDTM, SOP, SAP, and TLF. Actual mock-up tables for Safety, Efficacy, and Laboratory data are provided, along with a QC Checklist and Statistical Analysis Plan. Data validation and error checking represent essential components in sound clinical trial management and report writing.

The authors have done a superb job of conveying their years of combined experience in the writing of this text. A must-have book for those wishing to work in the pharmaceutical industry or clinical research field as a SAS programmer.

Jimmy Thomas Efird, Ph.D., M.Sc.
Director, Biostatistics and Data Management Facility
John A. Burns School of Medicine
Honolulu, Hawaii

 

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.