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JMESI - Clinical Investigation Questions and Answers
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JMESI - Clinical Investigation
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JMESI - Clinical InvestigationAn adverse event should be reported to the IRB, IRO, or HUC within: - answer72 hours
What oversight person, group, or mechanism has the authority to suspend or end an
approved investigation? - answerIRB, IRO, or HUC
Who is responsible for writing the clinical investigation (CI) research protocol? -
answerPrincipal investigator (PI)
As the principal investigator (PI), you are in charge of selecting and appointing a
medical monitor for the clinical investigation (CI) program. Of the following candidates,
who would be the best person for the job? - answerA nurse who has expertise in areas
of patient management and safety
What is the most critical aspect of carrying out a clinical investigation? - answerInformed
consent
Which of the following is a recommended component of a clinical investigation protocol?
- answerInvestigators
Which of the following is a guideline in human subject research? - answerPreparations
must be made for possible adverse events
Informed consent is rooted in which one of the following ethical principles? -
answerRespect for autonomy
The maxim, primum non nocere, is most closely associated with which ethical principle?
- answerNon-maleficence
Minors may be enrolled as experimental subjects when which of the following conditions
is met: - answerA legally authorized representative has authorized, in advance, for the
minor to participate in the clinical study
The appropriate name of the oversight committee concerned with clinical investigations
in the Air Force is: - answerInvestigational Review Board (IRB)
Which of the following is considered a responsibility of an Investigational Review Board
(IRB), Institutional Review Organization (IRO), or a Human Use Committee (HUC)? -
answernot looking at regs
not
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