CITI Training Practice Exam

To whom must the investigator report adverse events?

1. Subject

2. Sponsor

3. FDA

4. IRB only

The correct answer is: Sponsor

The investigator must report adverse events to the sponsor. Adverse events are unexpected and harmful side effects or reactions to an investigational product. Reporting adverse events to the sponsor allows them to track the safety of the product and make any necessary changes or adjustments. Reporting to other parties, such as the subject, FDA, or IRB only, is not sufficient as they may not have the authority or resources to take action on the reported events. It is important for the investigator to report adverse events to the sponsor in a timely and thorough manner to ensure the safety and efficacy of the investigational product.