Standard Operating Procedures

• 1-1 Post Approval Monitoring Protocol Selection
• 1-2 Notification of Review and Selection of Research Subject's Records
• 1-2A Letter of Notification
• 1-2B Cancer Center DSMC Notification of Review Letter
• 1-2C No Response from PI Letter
• 1-3 Regulatory Files Monitoring
• 1-3A Post Approval Monitoring Review Form
• 1-3B Post Approval Monitoring Review - Waiver of Consent
• 1-3C Post-Approval Monitoring IRB Questions/Findings
• 1-4 Consent Form Review
• 1-4A Informed Consent Verification Checklist
• 1-5 Review of Subject Records
• 1-5A Individual Subject Review Form
• 1-6 Reporting of PAM Findings
• 1-6A Post Approval Monitoring Report Form
• 1-7 Dissemination of PAM Findings
• 1-7A Transmittal Letter, Category 1
• 1-7A.2 VPRGS Letter, Exceptional
• 1-7B Transmittal Letter, Category 2
• 1-7B.2a VPRGS Letter, Satisfactory
• 1-7B.2b VPRGS Letter, Marginal
• 1-7C Transmittal Letter, Category 3
• 1-8 Function of the PAM Working Group