CITI Training Practice Exam

Which form represents a contractual agreement between the sponsor and FDA?

1. FDA 1571

2. FDA 2023

3. FDA 2000

4. FDA 1500

The correct answer is: FDA 1571

The correct answer, A (FDA 1571), represents a specific form that is used by the sponsor and FDA to enter into a contractual agreement. The other options (B, C, and D) do not accurately represent the required form for this type of agreement. Option B (FDA 2023) is a form used for drug listing, while option C (FDA 2000) is used for medical device registration. Option D (FDA 1500) is used for medical device premarket notifications, and is not applicable for contracts between sponsors and the FDA.