CITI Training Practice Exam 2026 - Free CITI Training Practice Questions and Study Guide

Question: 1 / 400

During the clinical development phase of the IND process, what must sponsors do?

Submit an NDA

Provide FDA with safety updates, copies of new protocols, FDA 1572, and Annual Progress reports

During the clinical development phase of the IND process, sponsors are responsible for providing the FDA with safety updates, copies of new protocols, the FDA 1572 form, and Annual Progress reports. Option A is incorrect because an NDA (New Drug Application) is submitted during the marketing phase. Option C is incorrect because the preclinical trial is completed before the IND process begins. Option D is incorrect because the marketing phase starts after the IND process is completed and the drug is approved by the FDA. Therefore, the correct answer is B.

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File a preclinical trial

Start the marketing phase

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