| Tools | Instructions |
| Data and Safety Monitoring Board Charter Template | Use this template, which outlines DSMB policies and procedures, when establishing a new Data and Safety Monitoring Board. |
| Note To File Template | Use this template to document any discrepancy, deviation, or missing material(s) in the study file so as to provide a complete history of the protocol. Retain this note with your regulatory documentation. |
Office of Regulatory Affairs and Research Compliance
