Biomedical Research Investigator's Manual

Last Updated: July 2003

Table of Contents
Cover and Table of Contents (6 pages)
Chapters 1-16 (59 pages)

Appendices
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 (31 pages)