Improving Adverse Event Report Processing at the U.S. Food and Drug Administration

Masucci, Clare Pennock

Student Work

Improving Adverse Event Report Processing at the U.S. Food and Drug Administration

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Adverse drug events, or unintended and dangerous drug effects, impact millions of people in the United States each year. Our goal was to increase the efficiency of adverse event case report processing at the United States Food and Drug Administration using business process improvement methods. Information was collected from shadowing and surveying staff, conducting interviews, and participating in meetings and presentations. Our recommendations focused on improving consumer education resources, enhancing the data entry user interface, utilizing new and existing metrics, and ultimately decreasing total report processing time and cost while considering the needs of the systemÂ’s stakeholders.

This report represents the work of one or more WPI undergraduate students submitted to the faculty as evidence of completion of a degree requirement. WPI routinely publishes these reports on its website without editorial or peer review.

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