Frederick W. Luthardt, DBE, MA, at Johns Hopkins University School of Medicine gives an overview of Data and Safety Monitoring Boards based on the DSMB Training Manual (mp4 video). He presents common problems and solutions facing DSMBs for investigator-initiated studies.


The CTSA Collaborative Data and Safety Monitoring Board (DSMB) Workgroup identified a need to provide guidance, training and resources in DSMB practices for investigator-initiated research studies. To promote clinical and translational research, the CTSA Collaborative DSMB Workgroup, supported by NCATS, has produced an online DSMB Training Manual with a focus on investigator-initiated studies. This manual provides information and training for Principal Investigators, DSMB members, IRB members, biostatisticians, and research staff on how to work effectively with DSMBs.

DSMB Manual

Download Version 1.0, Published May, 2018

Copyright and Citation


This manual is the work of the CTSA Collaborative DSMB Workgroup. This is a collaborative project by members of nine CTSAs who are experts in data and safety monitoring of research studies:

Learn About the CTSA Collaborative DSMB Workgroup

Would you like to know who we are, what we do, and how to join us? Click here.

Additional Resources & Useful Links

NIH Policies and Guidance for Data and Safety Monitoring of Clinical Trials

Selected Reference List (PDF)

Tufts Digital Library

These materials are permanently housed in the Tufts Digital Library.

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Comments and Questions

The CTSA Collaborative DSMB Workgroup Contributors welcome requests for use of this publication outside the scope of this license. For permission, or to share any questions or comments, please contact: