title: Creation and use of a database in clinical and translational research.
abstract: 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.
authors.affiliation: Department of Clinical Sciences, Division of Biostatistics, and daggerDepartment of Information Resources, UT Southwestern Medical Center, Dallas, TX 75390, USA. janet.smith@utsouthwestern.edu
authors.forename: Janet P
authors.initials: JP
authors.lastname: Smith
authors.forename: Alan C
authors.initials: AC
authors.lastname: Elliott
authors.forename: Linda S
authors.initials: LS
authors.lastname: Hynan
authors.forename: Joan S
authors.initials: JS
authors.lastname: Reisch
authors.forename: Stan A
authors.initials: SA
authors.lastname: Waddell
mesh_terms: D035843:Biomedical Research; D003625:Data Collection; D016208:Databases, Factual; D005260:Female; D006801:Humans; D008297:Male; D011786:Quality Control; D057170:Translational Research, Biomedical