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)

Via Media: Role and Responsibilities of the Independent Safety Officer

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.