CITI Training Practice Exam

If 30 days have elapsed since the FDA received an IND application without communication, can the trial commence?

1. Yes

2. No

3. Only with special permission

4. Only if it's a Phase IV trial

The correct answer is: Yes

If 30 days have elapsed since the FDA received an IND application without communication, then the trial can commence, and the correct answer is A. This is because according to FDA regulations, if the FDA has not requested any changes or additional information within that 30-day period, the sponsor may assume that the trial can move forward without any issues. Option B is incorrect because the question specifically states that 30 days have passed without communication from the FDA, meaning the trial can start. Option C is incorrect because special permission is not required if the FDA has not requested any changes within 30 days. Option D is incorrect because the phase of the trial does not affect the timeline for FDA communication and does not require special permission.