Case Study: Planning for Monitoring PCTs

Data and Safety Monitoring

Section 7

Case Study: Planning for Monitoring PCTs


Susan Ellenberg, PhD

Jeremy Sugarman, MD, MPH, MA

Doug Zatzick, MD


Contributing Editor

Gina Uhlenbrauck

The TSOS trial team had a proactive site visit and regulatory review with their sponsor liaison to the DSMB from the National Institutes of Mental Health. After the visit, they discussed learnings with the NIH Collaboratory Regulatory/Ethics Core and sponsor representatives. The site visit was treated as a knowledge exchange and was helpful to both the TSOS team and the sponsor. The visit helped the TSOS team work out issues such as how to obtain consent from patients remotely, the process for review of serious adverse events, and reporting to and interactions with the trial’s central IRB.

The TSOS principal investigator was concerned about having some level of oversight for adverse events that did not meet criteria for expedited submission to the IRB. The NIH Collaboratory Regulatory/Ethics Core of experts felt that the DSMB would provide an appropriate safety check in these instances. It was suggested that either the trial’s DSMB can review these events in aggregate or a subset of the DSMB (e.g., chair) may be asked to review individual adverse events when necessary. The mechanism for this review can be outlined in the DSMB charter to help establish an appropriate level of oversight.

The site visit required a lot of preparation and differed from traditional site visits in that there was more of a focus on IT aspects of the study. The sponsor representative had experience with electronic data capture systems and was able to provide some helpful input. After the discussions, the TSOS team was tasked with finalizing tables for data sorting and cleaning for the DSMB. The principal investigator expressed a need to be careful with the level of data cleaning, because the PCT is not resourced for staff to spend too much time on these tasks.

This visit and follow-up discussions show how a proactive dialog on data monitoring between the sponsor and investigator can benefit both entities and help to reach a mutually acceptable monitoring plan.



Version History

Published August 25, 2017


Ellenberg S, Sugarman J, Zatzick D. Data and Safety Monitoring: Case Study: Planning for Monitoring PCTs. 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: 10.28929/045.