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New! 01/29/2007
Policies and Procedures Manual
Last Updated: July 2003
Cover and Table of Contents
(7 pages)
Chapters 1 through 18
(91 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)
Social and Behavioral Sciences (IRB-C)
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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