CITI Training Exam Questions with All Correct Answers

CITI Training Exam Questions with All Correct Answers What is the term for management controls that are built in to a research study (for example, independent data analysis)? - Answer-Inherent controls An example of an individual financial COI is: - Answer-A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - Answer-There may be bias by the peer reviewer as to the area of research 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 COI management plan aims to: - Answer-Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed An example of an institutional COI is: - Answer-An industry sponsor pays for the construction of a new research laboratory at the organization An example of an individual financial COI is: - Answer-A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. 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