The Role of a Research Administration Program in Adverse Event Reporting‪.‬

Introduction Clinical research has endured remarkable and beneficial expansion in the past 25 years, although this growth has resulted in an unprecedented increase in workload for the human research protection system. Most of the expansion in clinical research has been in the form of multicenter trials, which present significant challenges for a local institutional review board (IRB). The dramatic increase in the number of multicenter clinical trials over the past two decades coincides with a tremendous influx of clinical trial funding from industry, which has resulted in the exposure of inadequacies in human subject protection programs developed to manage clinical trials on a smaller scale, usually at single sites (Morse, Califf, & Sugarman, 2001).