CITI Training Practice Exam

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What does it mean when a company is both producing and supplying the drug for use in the study?

  1. FDA

  2. Drug Supplier/Manufacturer

  3. Sponsor

  4. Sponsor-investigator

The correct answer is: Drug Supplier/Manufacturer

When a company is both producing and supplying the drug for use in the study, it means that they are responsible for creating and providing the drug that will be used in the study. This makes them the drug supplier/manufacturer, and this role is important as they hold the responsibility for ensuring the quality and consistency of the drug being tested. The other options are incorrect because FDA is the regulatory body responsible for reviewing and approving the study, sponsor is the entity that initiates and oversees the study, and sponsor-investigator is an individual who both conducts and financially supports the study. While these roles may be involved in the study, they are not responsible for producing and supplying the drug.

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