CITI Training Practice Exam

When the sponsor-investigator holds the IND, what is he or she responsible for annually reporting to the FDA?

1. IND renewal application

2. Adverse Event Summary Report

3. IND report

4. Marketing plan

The correct answer is: IND report

At the time the sponsor-investigator holds the IND, he or she is responsible for annually reporting to the FDA through an IND report. This report includes information such as the progress of the clinical investigation, any changes or amendments to the study protocol, and any reports of serious or unexpected adverse events. The other options, IND renewal application, Adverse Event Summary Report, and Marketing plan, are not annual reporting requirements for the sponsor-investigator. An IND renewal application is required every year to continue conducting the clinical investigation, but it is not an annual report. An Adverse Event Summary Report is submitted to the FDA on a quarterly basis, not annually. And a Marketing plan is not submitted to the FDA, as it is not relevant to the clinical investigation process. Therefore, option C is the most correct answer.