The Data Integrity and Safety Committee (DISC) is a multidisciplinary committee comprised of Cancer Center investigators and staff. The mission of the DISC is to provide oversight and monitoring of trials conducted by the Cancer Center. The DISC is committed to safeguarding trial subjects and ensuring that the validity and integrity of trial data and operations are upheld.

The center’s DISC is responsible for:

• Reviewing adverse events, unexpected problems, deviations and compliance with NIH, NCI and center policies
• Reviewing efficacy data and study results
• Reviewing audit reports
• Recommending appropriate actions to the PI, SRMC, and IRB

Cancer Center IITs and other trials without established data and safety monitoring boards will be reviewed by the SRMC to determine the appropriate level of monitoring required. Review frequency will be based upon the protocol’s level of risk to patients and its complexity.  All UF interventional IITs will be monitored no less than annually to ensure compliance with the protocol, IRB requirements and other applicable regulations. Additional clarifications for review requirements can be found on the UFHCC CTAT webpage at this link.

The DISC monitoring policies and procedures ensure compliance with policies and guidelines regarding data and safety monitoring from the National Institutes of Health and the National Cancer Institute.

Important Documents

• DISC Charter
• DISC Study Monitoring Report (Template)
• DISC Adverse Events Table (Template)
• DISC Protocol Deviations Table (Template)
• DISC Data & Safety Monitoring Plan
• DISC Reporting Requirements FAQ

Contact

For information related to the DISC please email UFHCC-DSMB@ach.ufl.edu.