Cancer Institute A national cancer institute
designated cancer center
Cancer Clinical Trials Office

Regulatory Resources

Regulatory Audits

The Stanford Cancer Institute Data and Safety Monitoring Committee (DSMC) is the auditing entity for all Cancer Institute research. The DSMC audits all investigator-initiated research, and reviews safety reports (Grade 3 and above), and protocol deviations for all Stanford Cancer Institute studies. The CCTO Regulatory Manager provides pre-audit assistance for studies selected for FDA audits, and completes pre-monitoring assessments for Investigator-Initiated research.

Industry Studies

Investigators contacted by an industry sponsor or CRO to schedule a monitoring session may contact CCTO-office@stanford.edu to reserve the Monitoring Conference Room CC2108.

Resources

Investigator Initiated Studies

Investigators participating in Stanford Investigator-Initiated studies will be notified by the DSMC when a study will be audited. For preparation assistance contact the CCTO Regulatory Manager at 650-736-0176.

Resources

FDA

All investigators must notify the CCTO Regulatory Manager at 650-736-0176 of a pending FDA audit. The CCTO will provide assistance with audit preparation.

Resources

Cooperative Group studies

All investigators must notify the Cooperative Group Regulatory Specialist at 650-724-0201 of a pending audit. The CCTO will provide assistance with audit preparation.

Stanford Medicine Resources:

Footer Links: