CITI Training Practice Exam

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Who reports the investigator's financial interests related to the clinical investigation to the FDA?

  1. The investigator's institution

  2. The investigator

  3. The IRB

  4. The sponsor

The correct answer is: The sponsor

Sponsors are responsible for reporting the investigator's financial interests related to the clinical investigation to the FDA. This is because sponsors are ultimately responsible for overseeing all aspects of the clinical trial, including ensuring that all financial conflicts of interest are properly reported and managed. The other options, such as the investigator's institution or the IRB, may also play a role in disclosing financial interests, but the ultimate responsibility lies with the sponsor. Additionally, the investigator may be required to report their financial interests to the sponsor, who will then report it to the FDA.

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