Monitoring for Serious Adverse Events

Data and Safety Monitoring

Section 5

Monitoring for Serious Adverse Events


Susan Ellenberg, PhD

Jeremy Sugarman, MD, MPH, MA

Doug Zatzick, MD


Contributing Editor

Gina Uhlenbrauck

In some PCTs with very ill populations, serious adverse events (SAEs) such as death may be expected outcomes. As in a traditional RCT with such a population, monitoring of individual SAEs is not likely to be helpful; however, monitoring comparative rates of SAEs between treatment arms can help to ensure that the study intervention is not causing more SAEs.



Version History

Published August 25, 2017


Ellenberg S, Sugarman J, Zatzick D. Data and Safety Monitoring: Monitoring for Serious Adverse Events. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated November 13, 2018. DOI: 10.28929/043.