GUIDELINES FOR MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS, CCOP RESEARCH BASES, AND THE CANCER TRIALS SUPPORT UNIT (CTSU) Prepared by: Clinical Trials Monitoring Branch Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis National Cancer Institute Revised October 2006

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 Clinical Drug Request 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

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