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.
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://tuftsctsi.wpengine.com/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)
- 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 Neuroscience Research Institute)
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
- The CTSA Collaborative DSMB Workgroup published an article in the June 2021 issue of the Journal of Investigative Medicine: Institutionally Chartered Data and Safety Monitoring Boards: Structured Approaches to Assuring Participant Safety in Clinical Research.
- The CTSA Collaborative DSMB Workgroup published an article, Independent Safety Officer, in Wikipedia. The article links to this web page.
- 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.
Every research study that includes volunteer participants requires safety monitoring in proportion to the risks of the study. Investigator-initiated clinical research can present unique regulatory challenges particularly for studies with a risk profile that warrants more oversight than minimal risk but less than for large, commercial, or high-risk research. The use of an independent safety officer (ISO) offers a middle way of right-sizing oversight to match the risk.
Independent safety officers are clinicians or researchers with relevant expertise who are independent of the investigator and the research study. This paper outlines their role, responsibilities, and discusses some of the issues that may be encountered in monitoring a study.
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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: DSMBmanual@gmail.com.