8. Which of the following are the three principles included in the Belmont Report?

Respect for Persons, Beneficence, Justice.

10. Adults with more than a 12-month history of migraines were assigned randomly in a double-blinded
study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy
measure was the reduction in severity of the migraine attacks. Enrollment was 1200 subjects. Which of
the following best describes the clinical phase of this study?

A. Phase III
B. Preclinical
C. Phase II
D. Phase I

11. Long-term toxicology of an experimental drug in animals most likely refers to which part of drug
development?

A. Phase III
B. Phase II
C. Preclinical
D. Phase I

12. Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely
refers to which clinical phase of a study in humans?

A. Phase II
B. Phase I
C. Phase II
D. Pre-clinical

13. The packaging of investigational drugs should ideally

A) look like a marketed product

B) allow subjects to identify placebo pills

C) be designed to help with subject compliance

D) be attractive so the study coordinators will use it

14. Who has ultimate responsibility for an investigational product?

A. Investigator
B. Clinical research coordinator
C. Sponsor
D. Pharmacist

15. Under which circumstance does the FDA allow verbal consent prior to participation in a research
study?
A. The subject has a legally authorized representative (LAR).
B. The study is minimal risk.
C. The subject is illiterate.
D. The study is greater than minimal risk.

16. An investigator is confronted with a life-threatening situation that necessitates using a test article
in a human subject who is unable to provide informed consent and there is no time to obtain consent
for the individual's legal representative. Under the FDA regulations, which of the following describes
the best course of action for the investigator:

a. The investigator and another physician agree that the situation necessitates the use of the test article.
An exception or waiver for informed consent can be made under these circumstances. The IRB will be
notified later. Correct

b. Do not use the test article until either the subject or the subject's legal representative can give
consent.

c. Use the test article without obtaining consent from the subject or the legal representative then notify
the IRB.

d. Submit a research protocol to the IRB and justify an expedited review approval of the consent
document so test article can be used immediately.