Quiz____?
An example of an institutional COI is: -
Answer✓✓
An industry sponsor pays for the construction of a new research laboratory at the
organization
Quiz____?
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
Quiz____?
During an Institutional Review Board (IRB) meeting, any IRB member who may have a
potential COI with a study under review should: -
Answer✓✓
Disclose their potential COI and may answer questions, but recuse themselves from voting
Quiz____?
A researcher's membership on an advisory board with an organization sponsoring research
can create a COI because: -
Answer✓✓
1
, It may be difficult for the researcher to appear neutral, as the researcher may have an
interest in the research's success
Quiz____?
The FDA regulations governing disclosure of individual COIs require: -
Answer✓✓
Applicants submitting marketing applications to disclose financial COIs of researchers who
conducted clinical studies
Quiz____?
An example of an individual financial COI is: -
Answer✓✓
A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also
the sponsor of the researcher's study.
Quiz____?
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
Quiz____?
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? -
Answer✓✓
2
, NCT number
Quiz____?
The Sunshine Act requires manufacturers to report "payments of transfers of value" for how
much annually? -
Answer✓✓
$10.00
Quiz____?
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? -
Answer✓✓
Clinical Trials Audit and Compliance
Quiz____?
Getting your proposal prepared for review and approval can be cumbersome. Which
department in the Office of Research Administration assists with proposal preparation? -
Answer✓✓
Research Administration Services (RAS)
Quiz____?
Which best matches the NIH definition of a clinical trial? -
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.
3
, Quiz____?
Adjudication of research participant's bills allows which department to direct charges to the
correct payer? -
Answer✓✓
Clinical Trials Billing Department (CTBD)
Quiz____?
To 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. -
Answer✓✓
True
Quiz____?
Non-licensed clinicians can dispense and educate subjects about their medication. -
Answer✓✓
False
Quiz____?
Which system provides the status of a clinical trial agreement (CTA)? -
Answer✓✓
Emory Contracts Tracking System (eCTS)
Quiz____?
4
An example of an institutional COI is: -
Answer✓✓
An industry sponsor pays for the construction of a new research laboratory at the
organization
Quiz____?
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
Quiz____?
During an Institutional Review Board (IRB) meeting, any IRB member who may have a
potential COI with a study under review should: -
Answer✓✓
Disclose their potential COI and may answer questions, but recuse themselves from voting
Quiz____?
A researcher's membership on an advisory board with an organization sponsoring research
can create a COI because: -
Answer✓✓
1
, It may be difficult for the researcher to appear neutral, as the researcher may have an
interest in the research's success
Quiz____?
The FDA regulations governing disclosure of individual COIs require: -
Answer✓✓
Applicants submitting marketing applications to disclose financial COIs of researchers who
conducted clinical studies
Quiz____?
An example of an individual financial COI is: -
Answer✓✓
A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also
the sponsor of the researcher's study.
Quiz____?
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
Quiz____?
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? -
Answer✓✓
2
, NCT number
Quiz____?
The Sunshine Act requires manufacturers to report "payments of transfers of value" for how
much annually? -
Answer✓✓
$10.00
Quiz____?
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? -
Answer✓✓
Clinical Trials Audit and Compliance
Quiz____?
Getting your proposal prepared for review and approval can be cumbersome. Which
department in the Office of Research Administration assists with proposal preparation? -
Answer✓✓
Research Administration Services (RAS)
Quiz____?
Which best matches the NIH definition of a clinical trial? -
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.
3
, Quiz____?
Adjudication of research participant's bills allows which department to direct charges to the
correct payer? -
Answer✓✓
Clinical Trials Billing Department (CTBD)
Quiz____?
To 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. -
Answer✓✓
True
Quiz____?
Non-licensed clinicians can dispense and educate subjects about their medication. -
Answer✓✓
False
Quiz____?
Which system provides the status of a clinical trial agreement (CTA)? -
Answer✓✓
Emory Contracts Tracking System (eCTS)
Quiz____?
4
