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
• NIA guidance on Data and Safety Monitoring
• NIDDK guidance on Data and Safety Monitoring Plans

NC TraCS DSMB Forms and Guidance

• DSMB Interim Report Form
• DSMB Quarterly Enrollment Report Form
• Developing a Data and Safety Monitoring Plan

To request a Letter of Support or a copy of the NC TraCS DSMB Charter, contact This email address is being protected from spambots. You need JavaScript enabled to view it..

Resources

• DSMB Training Manual