Validating Clinical Trial Data Reporting with SAS

Validating Clinical Trial Data Reporting with SAS

3.91 (12 ratings by Goodreads)
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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.
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Product details

  • Paperback | 224 pages
  • 191 x 235 x 12mm | 394g
  • United States
  • English
  • 1, black & white illustrations
  • 1599941287
  • 9781599941288
  • 884,426

Review quote

"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"
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Rating details

12 ratings
3.91 out of 5 stars
5 42% (5)
4 25% (3)
3 25% (3)
2 0% (0)
1 8% (1)
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