CITI Training Practice Exam

What is one of the investigator's commitments to the sponsor?

1. Submit documents to sponsor for yearly approval

2. Retain study documents for 3 years after study completion at the site

3. Provide the financial disclosure document directly to FDA

4. Submit a new FDA form 1572 to sponsor as needed

The correct answer is: Submit a new FDA form 1572 to sponsor as needed

One of the investigator's commitments to the sponsor is to submit a new FDA form 1572 as needed. This form is required by the FDA for any clinical trial involving an investigational drug or device. Option A is incorrect because submission of documents for yearly approval is not a specified commitment between the investigator and sponsor. Option B is incorrect because although retaining study documents for 3 years after study completion is important, it is not specifically a commitment to the sponsor. Option C is incorrect because providing the financial disclosure document directly to the FDA is not a commitment to the sponsor and is a separate requirement for clinical trials. Therefore, the correct answer is D.