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
- Monitoring Room Use and Network Connectivity
Sep 22, 2011 - HIPAA External Disclosure Form
Apr 2003
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
- Data and Safety Monitoring Committee SOP Sep 14, 2011
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
- FDA Audit SOP Dec 18, 2008
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.
Trial Administration