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Research

IND/IDE Resources

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Background

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When studies involve drugs or devices not approved by the Food & Drug Administration (FDA), or drugs or devices used for purposes not approved by the FDA which pose an increased risk, investigators are required to get clearance from the FDA prior to enrolling subjects in their study.

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Definitions

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Responsibilities

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Sponsor-Investigator Responsibilities under an IND

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Sponsor-Investigator Responsibilities under an IDE

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Additional Guidance

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Other Institutional Responsibilities

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PI’s Institutional Responsibility for Disclosure of FCOIs: See ‘Duties of Investigators’ section of the Financial Interests in Research Manual