Audit Assistance
The Stanford Cancer Center Data and Safety Monitoring Committee (DSMC) is the auditing entity for all Cancer Center research. The DSMC audits all investigator-initiated research, and reviews safety reports (Grade 3 and above), and protocol deviations for all Stanford Cancer Center 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 CCTOffice@stanford.edu to reserve the Monitoring Conference Room CC2108.
Resources
- Monitoring Room Use and Network Connectivity Mar 23, 2009
- 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 May 7, 2008
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