Reviews

"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"