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NIH Investigator Manual for Human Subjects Research
Table of Contents
Introduction
Chapter 1 - Types of Research: Human Subjects Research Vs. Not Human Subjects Research
Chapter 2 - Roles and Responsibilities of the Principal Investigator
Chapter 3 – Obtaining and Preparing Required Documents for IRB Initial Review
Chapter 4 - Writing Your Consent Document
Chapter 5 - Submitting Your Initial Review
Chapter 6 - Things To Do After IRB Approval But Before Starting Enrollment
Chapter 7 - Conducting Your Study
Chapter 8 - Subject Withdrawal from Research
Chapter 9 - Reporting Research Related Events or New Information to the IRB
Chapter 10 - Protocol Modifications
Chapter 11 - Continuing Reviews (CR)
Chapter 12 - Study closures (routine)
Chapter 13 - Conducting Research With Special Populations
Chapter 14 - FDA Regulated Research
Chapter 15 - International Research
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Investigator Manual
Created by
Swan, Jeremy (NIH/NICHD) [C]
, last modified by
Pauly, Kelly (NIH/OD) [E]
on
Mar 20, 2024
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