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Investigator Manual
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Contents
Prologue
Chapter 1. Introduction
Chapter 2. Application Submission
Chapter-3-The-SHIRB-Review-Process
Chapter 4. Informed Consent Requirements
Chapter 5. Risk Benefit Assessment
Chapter 6. Selection and Recruitment of Subjects
Chapter 7. Responsibilities of Principal Investigators
Chapter 8. Special Classes of Reseach Subjects
Chapter 9. FDA Requirements
Chapter 10. Glossary
Chapter 11. Application Forms
Chapter 12. Appendix
Chapter 13. Medical to Lay Terms
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