CITI Training Practice Exam

Who addresses the role of 'Sponsor-investigators'?

1. FDA

2. Drug Supplier/Manufacturer

3. Sponsor

4. Sponsor-investigator

The correct answer is: FDA

The FDA addresses the role of "Sponsor-investigators" as they are responsible for overseeing the conduct of a clinical trial and ensuring the safety and well-being of the participants. The drug supplier/manufacturer is involved in providing the drug or product being tested, but they do not have the same level of responsibility as the sponsor-investigator. The sponsor refers to the person or organization who initiates and funds the clinical trial, but they may not necessarily be directly involved in the day-to-day operations. The sponsor-investigator, on the other hand, is responsible for both the sponsor and the investigator roles and must adhere to all FDA regulations and guidelines. Therefore, option A is the most accurate choice as the FDA ultimately has regulatory oversight of the sponsor-investigator's actions.