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Home ▸ Biomedical Research Investigator's Manual

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)

 

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