Administrative Guidance
- 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
- 1-2D Letter of notification-waiver of consent w/ learning shot
- 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
- 1-6B Post Approval Monitoring Report Exempt Determination Form
- 1-7 Dissemination of PAM Findings
- 1-7A Transmittal Letter, Category 1
- 1-7A.2 VPR Letter, Exceptional
- 1-7B Transmittal Letter, Category 2
- 1-7B.2a VPR Letter, Satisfactory or Marginal without recommendations
- 1-7B.2b VPR Letter, Category 2 or 3 with additional recommendations
- 1-7C Transmittal Letter, Category 3
- 1-8 Function of the PAM Working Group
- 1-9 Consent Monitoring
- 1-10 Function of the IRB-HSR PAM Advisory Committee