JMESI - Clinical Investigation
An adverse event should be reported to the IRB, IRO, or HUC within:
→ 72 hours
What oversight person, group, or mechanism has the authority to suspend or end an
approved investigation?
→ IRB, IRO, or HUC
Who is responsible for writing the clinical investigation (CI) research protocol?
→ Principal 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?
→ A nurse who has expertise in areas of patient management and safety
What is the most critical aspect of carrying out a clinical investigation?
→ Informed consent
Which of the following is a recommended component of a clinical investigation protocol?
→ Investigators
Which of the following is a guideline in human subject research?
→ Preparations must be made for possible adverse events
Informed consent is rooted in which one of the following ethical principles?
→ Respect for autonomy
The maxim, primum non nocere, is most closely associated with which ethical principle?
→ Non-maleficence
Minors may be enrolled as experimental subjects when which of the following conditions is
met:
→ A 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:
→ Investigational Review Board (IRB)
An adverse event should be reported to the IRB, IRO, or HUC within:
→ 72 hours
What oversight person, group, or mechanism has the authority to suspend or end an
approved investigation?
→ IRB, IRO, or HUC
Who is responsible for writing the clinical investigation (CI) research protocol?
→ Principal 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?
→ A nurse who has expertise in areas of patient management and safety
What is the most critical aspect of carrying out a clinical investigation?
→ Informed consent
Which of the following is a recommended component of a clinical investigation protocol?
→ Investigators
Which of the following is a guideline in human subject research?
→ Preparations must be made for possible adverse events
Informed consent is rooted in which one of the following ethical principles?
→ Respect for autonomy
The maxim, primum non nocere, is most closely associated with which ethical principle?
→ Non-maleficence
Minors may be enrolled as experimental subjects when which of the following conditions is
met:
→ A 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:
→ Investigational Review Board (IRB)
