CITI Training Practice Exam

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Each practice test/flash card set has 50 randomly selected questions from a bank of over 500. You'll get a new set of questions each time!

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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
File a preclinical trial
Start the marketing phase

The correct answer is: 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.