Policies and Guidelines
- NIH Policy for Data and Safety Monitoring
- Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials
- NCI Data and Safety Monitoring Guidelines
NC TraCS DSMB Forms
- CTRC Safety Monitoring Plan template
- DSMB Report Form for Moderate-High Risk Trials (unblinded)
- DSMB Report Form Template
- Protection of Human Subjects for Grant Submissions
To request a Letter of Support or a copy of the NC TraCS DSMB Charter, please contact the DSMB Administrator, Marie Rape.
Susan S. Ellenberg, Thomas R. Fleming, and David L. DeMets. Data Monitoring in Clinical Trials: A Practical Perspective. John Wiley & Sons, Ltd, 2003.