CITI Training Practice Exam 2025 - Free CITI Training Practice Questions and Study Guide

Question: 1 / 400

Where can detailed requirements for the content and format of an IND be found?

21 CFR 50

21 CFR 312

The requirements for the content and format of an IND (Investigational New Drug application) can be found in 21 CFR (Code of Federal Regulations) 312. This regulation specifically outlines the information and documentation that must be included in an IND submission for approval from the FDA. It includes details about the proposed drug, its manufacturing process, and the clinical data and studies conducted. Therefore, options A, C, and D are incorrect as they refer to regulations that do not pertain to IND submissions. Option A refers to human subjects protection regulations, option C refers to electronic submission of import and export data, and option D refers to data quality and integrity requirements for clinical trials. Only option B, 21 CFR 312, covers the specific requirements for an IND.

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21 CFR 1571

21 CFR 1572

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