CITI Training Practice Exam

What entity is responsible for initiating a clinical investigation?

1. FDA

2. Drug Supplier/Manufacturer

3. Sponsor

4. Sponsor-investigator

The correct answer is: Sponsor

A clinical investigation is a research study that involves testing a medical product on human subjects. The Sponsor is responsible for initiating a clinical investigation. The FDA (choice A) is a regulatory agency that oversees and monitors clinical investigations, but does not initiate them. The Drug Supplier/Manufacturer (choice B) may provide the product for the investigation, but does not initiate it. The Sponsor-investigator (choice D) is an individual who both initiates and conducts the clinical investigation, but is not an entity responsible for initiating it. Therefore, the correct answer is C Sponsor.