Data and Safety Monitoring Board Training Manual Now Available
Posted by: Crystal Williams on: May 24, 2018 | Print This Page
This article is posted courtesy of Tufts University Clinical and Translational Science Institute (CTSI)
ICTR Research Participant Advocate, Frederick W. Luthardt, DBe, MA, contributed to the writing of this manual.
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.
Download Version 1.0, Published May, 2018
Copyright and Citation
- DSMB Training Manual by CTSA Collaborative DSMB Workgroup Contributors is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, except where otherwise noted.
- To cite this manual:
CTSA Collaborative DSMB Workgroup. DSMB Training Manual. Medford, MA: Tufts Digital Library; 2018 May [cited YYYY Month DD]. Available from: https://www.tuftsctsi.org/research-services/regulatory/data-and-safety-monitoring-board-training-manual-for-investigator-initiated-studies/
The DSMB Training Manual was supported by the Clinical and Translational Science Award (CTSA) Program at the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of any agency or organization that provided support for the project.
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:
- Barbara Hammack, PhD, Editor (University of Colorado, Denver, Colorado Clinical and Translational Sciences Institute)
- M.E. Blair Holbein, PhD, BACP, Editor (University of Texas, Southwestern Medical Center at Dallas, Center for Clinical and Translational Sciences)
- Tamsin A. Knox, MD, MPH, Editor (Tufts University, Tufts Clinical and Translational Science Institute)
- Laurel Yasko, MPPM, RN, CCRC, Editor (University of Pittsburgh, Clinical and Translational Science Institute)
- Frederick W. Luthardt, DBe, MA, Contributor (Johns Hopkins University, Institute for Clinical and Translational Research)
- Ann J. Melvin, MD, MPH, and Jason Malone, MPA, Contributors (University of Washington, Institution of Translational Health Sciences)
- Nancy Needler, BS, CCRC, Contributor (University of Rochester, Clinical and Translational Science Institute)
- Marie Rape, RN, BSN, Contributor (University of North Carolina, North Carolina Translational and Clinical Sciences Institute)
- Carson Reider, PhD, Contributor (The Ohio State University, Center for Clinical and Translational Science and The Neuroscience Research Institute)
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: DSMBmanual@gmail.com.