Drawing upon more than 30 years of experience in the drug industry, the author suggests how quality control principles proposed by W. Edwards Deming can be applied to case report form (CRF) processing. The transfer of information from patient visit to writing a final report is broken into 16 distinct steps. It is proposed that time to process be taken as a measure of quality. The author identifies a specific step—follow-up on queries to investigator sites—as the most variable of these steps in many programs and suggests methods for reducing the time involved. The author then identifies other steps that have high variability and suggests methods for improving them.
