Question

The investigator's financial interests with the pharmaceutical company (sponsor) or to the outcome of the clinical investigation is reported directly to the FDA by:

A) The investigator's institution
B) The investigator
C) The IRB
D) The sponsor

Answer 1

The financial interests of an investigator in connection with a pharmaceutical company or the outcome of a clinical investigation are reported to the FDA by the sponsor of the clinical trial.

Step-by-step explanation:

The investigator's financial interests with the pharmaceutical company (sponsor) or to the outcome of the clinical investigation should be reported directly to the FDA by the sponsor. According to FDA regulations, the sponsor is typically the entity responsible for the initiation, management, and financing of the clinical trial. They are expected to report any potential conflicts of interest that the investigators may have, as a way to ensure transparency and integrity in the research process.