What can we learn from a decade of database audits? The Duke Clinical Research Institute experience, 1997--2006.

Background Despite a pressing and well-documented need for better sharing of information on clinical trials data quality assurance methods, many research organizations remain reluctant to publish descriptions of and results from their internal auditing and quality assessment methods.Purpose We present findings from a review of a decade of internal data quality audits performed at the Duke Clinical Research Institute, a large academic research organization that conducts data management for a diverse array of clinical studies, both academic and industry-sponsored. In so doing, we hope to stimulate discussions that could benefit the wider clinical research enterprise by providing insight into methods of optimizing data collection and cleaning, ultimately helping patients and furthering essential research.Methods We present our audit methodologies, including sampling methods, audit logistics, sample sizes, counting rules used for error rate calculations, and characteristics of audited trials. We also present ...