Article Text

Creation and Use of a Database in Clinical and Translational Research
  1. Janet P. Smith, BA*,
  2. Alan C. Elliott, MS*,
  3. Linda S. Hynan, PhD*,
  4. Joan S. Reisch, PhD*,
  5. Stan A. Waddell, MS
  1. From the *Department of Clinical Sciences, Division of Biostatistics, and †Department of Information Resources, UT Southwestern Medical Center, Dallas, TX.
  1. Received October 19, 2009, and in revised form October 29, 2009.
  2. Accepted for publication November 6, 2009.
  3. Reprints: Janet P. Smith, BA, Department of Clinical Sciences, Division of Biostatistics, UT Southwestern Medical Center, Dallas, TX 75390. E-mail: janet.smith{at}
  4. There are no conflicts of interest.


Often data collection for clinical studies is an afterthought. The results of such an approach are incomplete or confusing data that can, as a worst case, result in scrapping and restarting the entire study. We discuss the planning process for data collection and storage to include encounter form development; data flow and capture; data checking, verification, and validation; advantage of relational databases over spreadsheets; data security; and aspects of a complete data system.

Key Words
  • database
  • forms design
  • security

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