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  New! 01/29/2007

Biomedical Research Investigator's Manual
Last Updated: July 2003

• Cover and Table of Contents
  (6 pages)
• Chapters 1 through 16
  (59 pages)
• Appendix I - Glossary of Frequently Used Terms
  (10 pages)
• Appendix II - IRB Forms
• Appendix III - Informed Consent Templates
• Biomedical Research (IRB-A and IRB-B)
• Joint MRI-GU Oncology (IRB-D)
• Appendix IV - Ethics References
  (20 pages)
• Appendix V - Regulations and Standards
• V-A - FDA Regulations at 21 CFR Part 50
  (9 pages)
• V-B - FDA Regulations at 21 CFR Part 54
  (4 pages)
• V-C - FDA Regulations at 21 CFR Part 56
  (9 pages)
• V-D - FDA Regulations at 21 CFR Part 312
  (39 pages)
• V-E - FDA Regulations at 21 CFR Part 600
  (15 pages)
• V-F - FDA Regulations at 21 CFR Part 812
  (19 pages)
• V-H - FDA Regulations at 21 CFR Part 50, Subpart F
  (4 pages)
• V-I - FDA Regulations at 21 CFR Part 46
  (22 pages)
• V-N - International Conference on Harmonisation - Guidelines on Good Clinical Practice [ICH-GCP]
  (57 pages)
• [V-G (FDA Non-Significant and Significant Risk Device Examples), V-J (DHHS/FDA Expedited Review List), V-K (DHHS Draft Interim Guidance on Financial Relationships in Clinical Research -January 2001), V-L (Public Law 103-43), V-M (OHRP Sample "Short Form" for Translation into Languages Understandable to Subjects)]
  (25 pages)
• Appendix VI - Georgetown University Requirements
  (30 pages)

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