CITI TRAINING Exam Questions and Answers (Latest Update 2024)
An example of an institutional COI is: - Correct Answer ✅An
industry sponsor pays for the construction of a new research laboratory at the organization
The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - Correct Answer ✅There may be bias by
the peer reviewer as to the area of research
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: - Correct Answer ✅Disclose their potential COI and may answer questions, but recuse themselves from voting
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: - Correct Answer ✅It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the
research's success CITI TRAINING Exam Questions and Answers (Latest Update 2024)
The FDA regulations governing disclosure of individual COIs require: - Correct Answer ✅Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
An example of an individual financial COI is: - Correct Answer ✅A researcher's spouse 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. - Correct Answer ✅No later than the time of proposal submission
For clinical trials, what should be reported to the Office for Clinical Research (OCR) to confirm ClinicalTrials.gov registration and for the purpose of ensuring Medicare reimbursement? - Correct Answer ✅NCT number CITI TRAINING Exam Questions and Answers (Latest Update 2024)
The Sunshine Act requires manufacturers to report "payments
of transfers of value" for how much annually? - Correct Answer ✅$10.00
Which department reviews a sample of clinical trials being conducted in each department and provides education, tools,
and corrective and preventative action plans, when needed? -
Correct Answer ✅Clinical Trials Audit and Compliance
Getting your proposal prepared for review and approval can be cumbersome. Which department in the Office of Research Administration assists with proposal preparation? - Correct Answer ✅Research Administration Services (RAS)
Which best matches the NIH definition of a clinical trial? - Correct Answer ✅A research study in which one or more humans subjects are assigned to evaluate the effects of those
interventions involving health-related biomedical and behavioral outcomes. CITI TRAINING Exam Questions and Answers (Latest Update 2024)
Adjudication of research participant's bills allows which department to direct charges to the correct payer? - Correct Answer ✅Clinical Trials Billing Department (CTBD)
T o facilitate Pre-award submissions and their approval, the study team should submit to the Institutional Review Board (IRB) at the same time they are submitting to OCR, and OSP/OTT. - Correct Answer ✅True
Non-licensed clinicians can dispense and educate subjects about their medication. - Correct Answer ✅False
Which system provides the status of a clinical trial agreement
(CTA)? - Correct Answer ✅Emory Contracts Tracking System
(eCTS)
If the FDA schedules an appointment to inspect your studies, which department at Emory should you contact first in preparation for the FDA visit? - Correct Answer ✅Office of Compliance
An example of an institutional COI is: - Correct Answer ✅An
industry sponsor pays for the construction of a new research laboratory at the organization
The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - Correct Answer ✅There may be bias by
the peer reviewer as to the area of research
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: - Correct Answer ✅Disclose their potential COI and may answer questions, but recuse themselves from voting
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: - Correct Answer ✅It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the
research's success CITI TRAINING Exam Questions and Answers (Latest Update 2024)
The FDA regulations governing disclosure of individual COIs require: - Correct Answer ✅Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
An example of an individual financial COI is: - Correct Answer ✅A researcher's spouse 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. - Correct Answer ✅No later than the time of proposal submission
For clinical trials, what should be reported to the Office for Clinical Research (OCR) to confirm ClinicalTrials.gov registration and for the purpose of ensuring Medicare reimbursement? - Correct Answer ✅NCT number CITI TRAINING Exam Questions and Answers (Latest Update 2024)
The Sunshine Act requires manufacturers to report "payments
of transfers of value" for how much annually? - Correct Answer ✅$10.00
Which department reviews a sample of clinical trials being conducted in each department and provides education, tools,
and corrective and preventative action plans, when needed? -
Correct Answer ✅Clinical Trials Audit and Compliance
Getting your proposal prepared for review and approval can be cumbersome. Which department in the Office of Research Administration assists with proposal preparation? - Correct Answer ✅Research Administration Services (RAS)
Which best matches the NIH definition of a clinical trial? - Correct Answer ✅A research study in which one or more humans subjects are assigned to evaluate the effects of those
interventions involving health-related biomedical and behavioral outcomes. CITI TRAINING Exam Questions and Answers (Latest Update 2024)
Adjudication of research participant's bills allows which department to direct charges to the correct payer? - Correct Answer ✅Clinical Trials Billing Department (CTBD)
T o facilitate Pre-award submissions and their approval, the study team should submit to the Institutional Review Board (IRB) at the same time they are submitting to OCR, and OSP/OTT. - Correct Answer ✅True
Non-licensed clinicians can dispense and educate subjects about their medication. - Correct Answer ✅False
Which system provides the status of a clinical trial agreement
(CTA)? - Correct Answer ✅Emory Contracts Tracking System
(eCTS)
If the FDA schedules an appointment to inspect your studies, which department at Emory should you contact first in preparation for the FDA visit? - Correct Answer ✅Office of Compliance
