CNPR EXAM EXPECTED QUESTIONS
WITH VERIFIED ANSWERS
Question 1.
approvable letter
ANSWER
letters sent by the FDA to the applicant indicating whether the new drug application meets
necessary requirements.
Question 2.
asymptomatic
ANSWER
without sings or symptoms of disease.
Question 3.
blinded or masked study
ANSWER
a study in which participants do not know whether they are in the experimental or control
group in a research study.
Question 4.
control or control group
ANSWER
the standard by which experimental observations are evaluated.
Question 5.
double-blind or double masked study
ANSWER
one in which neither the participants nor the study staff know which participants. are
receiving the experimental treatment and which ones are getting either a standard treatment
or a placebo.
,Question 6.
edema
ANSWER
swelling.
Question 7.
fast-track drugs
ANSWER
fast-track approval is provided for drugs that meet medical needs for patients with serious or
life-threatening conditions.
Question 8.
indication
ANSWER
in terms of drugs approval, the exact cause or purpose for which the FDA has approved that a
drug can be prescribed
Question 9.
institutional review board (IRB)
ANSWER
committee of physicians, statisticians, community advocated, and others which ensure that a
clinical trial is ethical and that the rights of the study participants are protected. All clinical
trials must be approved by an IRB before they begin.
Question 10.
off label
ANSWER
usage of a medication for purposes other than the specific ones appearing in the labeling.
, Question 11.
placebo
ANSWER
inactive pill, liquid, or powder that has no treatment value.
Question 12.
placebo effect
ANSWER
the effect produced by a placebo due to the expectations of the patient.
Question 13.
study protocol
ANSWER
the general design and operating features of a trial. it is distinguished from the study manual
of operations by its generality and absence of specific details needed for day-to-day
execution of the trial.
Question 14.
toxicity
ANSWER
the extent, quality, or degree to which a substance is a poisonous or harmful to the body.
Question 15.
treatment group
ANSWER
a group of patients assigned to receive a specified treatment.
Question 16.
anatomy
ANSWER
study of the basic structures of the body.
WITH VERIFIED ANSWERS
Question 1.
approvable letter
ANSWER
letters sent by the FDA to the applicant indicating whether the new drug application meets
necessary requirements.
Question 2.
asymptomatic
ANSWER
without sings or symptoms of disease.
Question 3.
blinded or masked study
ANSWER
a study in which participants do not know whether they are in the experimental or control
group in a research study.
Question 4.
control or control group
ANSWER
the standard by which experimental observations are evaluated.
Question 5.
double-blind or double masked study
ANSWER
one in which neither the participants nor the study staff know which participants. are
receiving the experimental treatment and which ones are getting either a standard treatment
or a placebo.
,Question 6.
edema
ANSWER
swelling.
Question 7.
fast-track drugs
ANSWER
fast-track approval is provided for drugs that meet medical needs for patients with serious or
life-threatening conditions.
Question 8.
indication
ANSWER
in terms of drugs approval, the exact cause or purpose for which the FDA has approved that a
drug can be prescribed
Question 9.
institutional review board (IRB)
ANSWER
committee of physicians, statisticians, community advocated, and others which ensure that a
clinical trial is ethical and that the rights of the study participants are protected. All clinical
trials must be approved by an IRB before they begin.
Question 10.
off label
ANSWER
usage of a medication for purposes other than the specific ones appearing in the labeling.
, Question 11.
placebo
ANSWER
inactive pill, liquid, or powder that has no treatment value.
Question 12.
placebo effect
ANSWER
the effect produced by a placebo due to the expectations of the patient.
Question 13.
study protocol
ANSWER
the general design and operating features of a trial. it is distinguished from the study manual
of operations by its generality and absence of specific details needed for day-to-day
execution of the trial.
Question 14.
toxicity
ANSWER
the extent, quality, or degree to which a substance is a poisonous or harmful to the body.
Question 15.
treatment group
ANSWER
a group of patients assigned to receive a specified treatment.
Question 16.
anatomy
ANSWER
study of the basic structures of the body.
