Guidelines for Monitoring of Clinical Trials for Cooperative Groups, CCOP Research Bases, and the Cancer Trials Support Unit (CTSU)

Revised October 2006

CTMB Guidelines

Appendix 1 (PDF)

• CTSU Standard Operating Procedures

Appendix 2 (PDF)

• Optional CTMB checklist

Appendix 3 (PDF)

• Title 45 CFR part 46
• Continuing Review Document
• Expedited Review Procedures

Appendix 4 (PDF)

• Investigational Agent Accountability Record
• PMB Section 15 from Investigator's Handbook
• Return Investigational Agent Form
• Transfer Investigational Agent Form

Appendix 5 (PDF)

• Group Preliminary Report Template
• Co-site Preliminary Report Template

Appendix 6 (PDF)

• Group Final Report Template
• Co-site Final Report Template