DSMB Training Manual for Investigator Initiated Studies
Overview
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
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/
- 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.
Authors
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