Exam (elaborations)
JMESI-US006 - Clinical Investigation Questions and Answers 2024
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JMESI-US006 - Clinical Investigation
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JMESI-US006 - Clinical InvestigationWho is responsible for writing the clinical investigation (CI) research protocol? - answer
Principal investigator (PI)
What is the most critical aspect of carrying out a clinical investigation? - answer
Informed consent
Which of the following is a recommended component of a clinical investigation protocol?
- answer Investigators
An adverse event should be reported to the IRB, IRO, or HUC within: - answer72 hours
Which of the following is a guideline in human subject research? - answer Preparations
must be made for possible adverse events
The maxim, primum non nocere, is most closely associated with which ethical principle?
- answerNon-maleficence
Which of the following is a component of the communications strategy message to
stakeholders? - answerThe current research at your healthcare organization
The appropriate name of the oversight committee concerned with clinical investigations
in the Air Force is: - answerInvestigational Review Board (IRB)
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 would best describe the role of the medical monitor? - answerAdvocate
Informed consent is rooted in which one of the following ethical principles? -
answerRespect for autonomy
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
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