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.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. Available at: http://www.hhs.gov/ocr/privacy/. Accessed November 25, 2009.
