JMESI-US006 JMESI - Clinical
Investigation (1 hr)
Which of the following is a guideline in human subject research – CORRECT ANSWER:
Preparations must be made for possible adverse events
Who is responsible for writing the clinical investigation research protocol – CORRECT
ANSWER: Principal investigator
The appropriate name of the oversight committee concerned with clinical investigations in
the Air Force – CORRECT ANSWER: IRB
Adverse event should be reported to the IRB, IRO, or HUC within – CORRECT
ANSWER: 72 hours
Which of the following is a recommended component of a clinical investigation protocol –
CORRECT ANSWER: Investigators
Which of the following is a component of the communications strategy message to
stakeholder – CORRECT ANSWER: Current research at your HCMO
Minors may be enrolled as experimental subjects when which of the following conditions is
met – CORRECT ANSWER: A legally authorized representative has authorized, in advance,
for the minor to participate
As the principal investigator, you are in charge of selecting and appointing a medical
monitor for the clinical investigation program. Of the following, who would be the best
person for the job – CORRECT ANSWER: A nurse who has experience in areas of patient
management and safety
Informed consent is rooted in which one of the following ethical principles – CORRECT
ANSWER: Respect for autonomy
Maxim, primum non nocere, is most closely associated with which ethical principle –
CORRECT ANSWER: Non-maleficence
What is the most critical aspect of carrying out a CI – CORRECT ANSWER: Informed
consent
Investigation (1 hr)
Which of the following is a guideline in human subject research – CORRECT ANSWER:
Preparations must be made for possible adverse events
Who is responsible for writing the clinical investigation research protocol – CORRECT
ANSWER: Principal investigator
The appropriate name of the oversight committee concerned with clinical investigations in
the Air Force – CORRECT ANSWER: IRB
Adverse event should be reported to the IRB, IRO, or HUC within – CORRECT
ANSWER: 72 hours
Which of the following is a recommended component of a clinical investigation protocol –
CORRECT ANSWER: Investigators
Which of the following is a component of the communications strategy message to
stakeholder – CORRECT ANSWER: Current research at your HCMO
Minors may be enrolled as experimental subjects when which of the following conditions is
met – CORRECT ANSWER: A legally authorized representative has authorized, in advance,
for the minor to participate
As the principal investigator, you are in charge of selecting and appointing a medical
monitor for the clinical investigation program. Of the following, who would be the best
person for the job – CORRECT ANSWER: A nurse who has experience in areas of patient
management and safety
Informed consent is rooted in which one of the following ethical principles – CORRECT
ANSWER: Respect for autonomy
Maxim, primum non nocere, is most closely associated with which ethical principle –
CORRECT ANSWER: Non-maleficence
What is the most critical aspect of carrying out a CI – CORRECT ANSWER: Informed
consent
