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Quality Assurance/Quality Improvement vs. Research

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Regulations & guidance governing human subject research

The Belmont Report:  Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Code of Federal Regulations (FDA) Title 21, Part 50 [21 CFR 50] -- Protection of Human Subjects

Code of Federal Regulations (FDA) Title 21, Part 56 [21 CFR 56] -- Institutional Review Boards

Code of Federal Regulations (FDA) Title 21, Part 312 [21 CFR 312] -- Investigational New Drug Application

Code of Federal Regulations (FDA) Title 21, Part 812 [21 CFR 812] -- Investigational Device Exemptions

Code of Federal Regulations (DHHS)
Title 45, Part 46 [45 CFR 46]

ICH Guideline for Good Clinical Practice

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