Trial Innovation Network Collaboration Webinar, Wednesday, November 14 at noon ET

DSMB Operations: Nuggets for Investigator-initiated Clinical Research

Carson Reider, PhD, The Ohio State University
Frederick W. Luthardt, DBe, MA, Johns Hopkins University

Historically, guidelines and policy for data and safety monitoring boards have focused on their operations for large multi-center clinical trials; however, there exists and need for their inclusion in and understanding of their function for a variety of investigator-initiated studies. A CTSA-based DSMB workgroup has devoted its energies to provide guidance in this niche for DSMBs and for individuals who may serve on them.

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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:

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.

The Tufts Digital Library is a centrally-managed preservation and access system for digital content of enduring value created at Tufts and/or by members of the Tufts community, its affiliates, and allied organizations. The TDL’s backend architecture is built around Fedora Commons Repository, an open-source digital repository management system. Services include long-term and archival storage of digital objects, as well as public access where appropriate.

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: