CITI Training Practice Exam

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When do Annual Reports need to be submitted to the FDA?

Within sixty (60) days of the end of the fiscal year
Within thirty (30) days of the anniversary date that the IND went into effect
Within sixty (60) days of the anniversary date that the IND went into effect
At the end of the calendar year

The correct answer is: Within sixty (60) days of the anniversary date that the IND went into effect

Annual Reports need to be submitted to the FDA within sixty (60) days of the anniversary date that the IND went into effect. Option A is incorrect because it states a timeframe for the end of the fiscal year, not the anniversary date of the IND. Option B is incorrect because it refers to the IND going into effect, not the submission of the Annual Report. Option D is incorrect because it specifies the end of the calendar year, not the anniversary date of the IND. Therefore, the correct answer is option C.