Richard C. Zink is Principal Research Statistician Developer in the JMP Life Sciences division at SAS Institute. He joined SAS in 2011 after eight years in the pharmaceutical industry, where he designed and analyzed clinical trials in multiple therapeutic areas and participated in US and European drug submissions and FDA advisory committee hearings. Richard is the Statistics Section Editor for Therapeutic Innovation & Regulatory Science (formerly Drug Information Journal), and holds a Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill. Follow him at @rczink.
In a clinical trial, when a subject has a serious adverse event (SAE) or other significant adverse event (AE), such as those leading to the discontinuation of the study, a narrative is written for the clinical study report. These narratives summarize the details surrounding the event to enable understanding of