The CCTS Regulatory Knowledge and Support Unit's Data Safety Monitoring Board (DSMB) conducts interim monitoring and oversight of CCTS supported trials. The DSMB is comprised of a core multidisciplinary team with Ad hoc members appointed as needed to provide specialized expertise.
To determine if your study qualifies for the CCTS DSMB, click here.
The DSMB meets three times a year and protocols are scheduled for review prior to initiation and then on an interim basis during the trial.
- Adverse Event Log Example (xls)
- Adverse Event Log with Key Header (xls)
- Adverse Event Log with Key Separate (xls)
- Charter (pdf)
- Initial Review (docx)
- IRB Log (xls)
- DSMB Interim Review (docx)
- Membership List (docx)
- Principal Investigator 101
- Protocol Violation Log (docx)
- Reporting SAE, AE, withdrawals and protocol violations (docx)
- Study Inactivation or Closure (docx)
- Study Overview Template (xls)
- Withdrawal Log (docx)