Policies and Procedures Manual

Last Updated: February 2020

Table of Contents
Cover and Table of Contents (6 pages)
Chapters 1-17 (83 pages)

Appendices
Appendix I – Ethics References (21 pages)

Appendix II – Regulations and Standards: II-A – FDA Informed Consent Regulations at 21 CFR Part 50 II-B – FDA Financial Disclosure by Clinical Investigators Regulations at 21 CFR Part 54 II-C – FDA IRB Regulations at 21 CFR Part 56 II-D – FDA Investigational New Drug Regulations at 21 CFR Part 312 II-E – FDA Biological Products Regulations at 21 CFR Part 600 II-F – FDA Investigational Device Regulations at 21 CFR Part 812 II-G – PHS Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought Regulations at 21 CFR Part 54, Subpart F II-H – DHHS Human Subject Regulations at 45 CFR Part 46 II-I – International Conference on Harmonisation – Guidelines on Good Clinical Practice [ICH-GCP] II-J FDA Non-Significant and Significant Risk Device Examples II-K DHHS/FDA Expedited Review List

Appendix III – Georgetown University Requirements (12 pages)