FIPP 4 - Exam 1 Questions and Correct
Answers
Question 1
Which of the following is an objective of a phase 1 study?
Correct Answer
to assess a safe and tolerated dose
Question 2
Select the two techniques that are commonly utilized in pharmacoepidemiology?
Correct Answer
- data mining
- observational studies
Question 3
Drug sale representatives must comply with FDA rules and regulations which include
all of the following, EXCEPT:
Correct Answer
discussing all indications for a drug, regardless of FDA approval, provided they have
an exemption from the FDA to allow such discussion
Question 4
Which FDA book lists generic equivalents for a brand name drug?
Correct Answer
FDA Orange Book
Page 1 of 9
, Question 5
Which is the correct order of how a bill becomes a law at the state level?
Correct Answer
Senator puts an idea into writing -> bill is assigned to a committee -> bill is
brought to the floor -> bill moves to the house -> bill is sent to the governer
Question 6
Which of the following is the definition of a commercial IND in regard to requesting
to start clinical trials?
Correct Answer
pharmaceutical companies whose ultimate goal is to obtain marketing approval for
new products
Question 7
Roles and responsibilities of Medical Science Liasons include which of the following?
(select all that apply)
Correct Answer
- facilitate investigator-initiated research and medical education grants
- align and execute field activities in support of medical affairs strategic plan
Question 8
Which definition best describes health disparities?
Correct Answer
preventable differences in the burden of disease, injury, violence, or opportunities
to achieve optimal health that are experienced by socially disadvantaged
populations
Question 9
A study found that the placebo had a 20% response rate and the treatment had a
60% response rate. What is the ARR and NNT?
Correct Answer
ARR= 40%
NNT= 3
Page 2 of 9
Answers
Question 1
Which of the following is an objective of a phase 1 study?
Correct Answer
to assess a safe and tolerated dose
Question 2
Select the two techniques that are commonly utilized in pharmacoepidemiology?
Correct Answer
- data mining
- observational studies
Question 3
Drug sale representatives must comply with FDA rules and regulations which include
all of the following, EXCEPT:
Correct Answer
discussing all indications for a drug, regardless of FDA approval, provided they have
an exemption from the FDA to allow such discussion
Question 4
Which FDA book lists generic equivalents for a brand name drug?
Correct Answer
FDA Orange Book
Page 1 of 9
, Question 5
Which is the correct order of how a bill becomes a law at the state level?
Correct Answer
Senator puts an idea into writing -> bill is assigned to a committee -> bill is
brought to the floor -> bill moves to the house -> bill is sent to the governer
Question 6
Which of the following is the definition of a commercial IND in regard to requesting
to start clinical trials?
Correct Answer
pharmaceutical companies whose ultimate goal is to obtain marketing approval for
new products
Question 7
Roles and responsibilities of Medical Science Liasons include which of the following?
(select all that apply)
Correct Answer
- facilitate investigator-initiated research and medical education grants
- align and execute field activities in support of medical affairs strategic plan
Question 8
Which definition best describes health disparities?
Correct Answer
preventable differences in the burden of disease, injury, violence, or opportunities
to achieve optimal health that are experienced by socially disadvantaged
populations
Question 9
A study found that the placebo had a 20% response rate and the treatment had a
60% response rate. What is the ARR and NNT?
Correct Answer
ARR= 40%
NNT= 3
Page 2 of 9
