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CITI SPD EXAM 2025 QUESTIONS AND ANSWERS The FDA regulations governing disclosure of individual COIs require: ....ANSWER ...-Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? - ....ANSWER ...-Researcher What is the term for management controls that are built in to a research study (for example, independent data analysis)? - ....ANSWER ...-Inherent controls A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: - ....ANSWER ...-It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. - ....ANSWER ...-No later than the time of proposal submission A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the ...©️ 2025, ALL RIGHTS RESERVED 1