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

Liz Wing, MA

In some ePCTs, serious adverse events (SAEs) such as death may be an expected outcome (e.g., suicide prevention trials [Sisti et al. 2018] or studies with very ill populations). 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.




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Sisti DA, Joffe S. 2018. Implications of zero suicide for suicide prevention research. JAMA. 320:1633–1634. doi:10.1001/jama.2018.13083.

Version History

December 13, 2018: Added a new reference as part of annual content update (L. Wing).

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 December 13, 2018. DOI: 10.28929/043.