ACRP CCRC PRACTICE SOLUTION REVIEW
SHEET TESTED QUESTIONS AND CORRECT
ANSWERS
⩥ A subject is issued 120 tablets and is instructed to take 2 tablets 4
times a day. He returns 88 tablets on the morning of day 9 fasting for
laboratory tests. What percent compliant is he?
Answer: 50%
⩥ Twenty-six subjects were enrolled in a pneumonia trial. The site
received 100 bottles of IP. Each subject received two bottles. Four
subjects did not return their trial bottles. How many bottles are available
for the CRC to return to the sponsor at the end of the trial?
Answer: 92
⩥ A subject is participating in a clinical trial where only the pharmacist
and the sponsor know the identity of the IP. The pharmacist has no direct
contact with the trial subject and the clinical team. Which of the
following BEST describes this trial type?
Answer: double-blind
⩥ double-blind trial
Answer: study where participants and the study team interacting with
them (investigator, arc) are unaware of treatment allocation
,⩥ A clinical trial is being conducted to determine the safety and
tolerability of a new anti-emetic IP. The sponsor expects to enroll 20
subjects. This would be considered a
Answer: Phase 1 Trial
⩥ Phase 1 Trials primary objective
Answer: non-therapeutic objectives, intended to determine tolerability of
dose ranges for future trials, and determine the nature of adverse events
that may be expected
⩥ Phase 1 trials typically have a ________ group of subjects enrolled.
Answer: small
⩥ Open-label trial
Answer: both the researchers and subjects know which treatment is
being administered
⩥ Single-blind trial
Answer: subjects are not aware of which treatment is administered,
researchers do know
⩥ therapeutic efficacy
, Answer: ability of a treatment (drug, therapy) to produce its intended
beneficial effects
⩥ Phase 2 trials primary objective
Answer: to explore therapeutic efficacy
⩥ Phase 3 trials primary objective
Answer: to demonstrate, or confirm therapeutic benefit
⩥ Phase 4 trials begin _________ drug approval by the FDA.
Answer: after
⩥ Phase 4 trials primary objective
Answer: to monitor the long-term safety, effectiveness, and optimal use
of an approved drug in the general population after approval, identifying
rare side effects or risks missed in earlier controlled studies, and
exploring new uses, doses, or combinations in real-world settings
⩥ PK Sampling
Answer: Involves collecting biological samples at specific times after
the drug is given to understand how the BODY absorbs, distributes,
metabolizes, and excretes it
SHEET TESTED QUESTIONS AND CORRECT
ANSWERS
⩥ A subject is issued 120 tablets and is instructed to take 2 tablets 4
times a day. He returns 88 tablets on the morning of day 9 fasting for
laboratory tests. What percent compliant is he?
Answer: 50%
⩥ Twenty-six subjects were enrolled in a pneumonia trial. The site
received 100 bottles of IP. Each subject received two bottles. Four
subjects did not return their trial bottles. How many bottles are available
for the CRC to return to the sponsor at the end of the trial?
Answer: 92
⩥ A subject is participating in a clinical trial where only the pharmacist
and the sponsor know the identity of the IP. The pharmacist has no direct
contact with the trial subject and the clinical team. Which of the
following BEST describes this trial type?
Answer: double-blind
⩥ double-blind trial
Answer: study where participants and the study team interacting with
them (investigator, arc) are unaware of treatment allocation
,⩥ A clinical trial is being conducted to determine the safety and
tolerability of a new anti-emetic IP. The sponsor expects to enroll 20
subjects. This would be considered a
Answer: Phase 1 Trial
⩥ Phase 1 Trials primary objective
Answer: non-therapeutic objectives, intended to determine tolerability of
dose ranges for future trials, and determine the nature of adverse events
that may be expected
⩥ Phase 1 trials typically have a ________ group of subjects enrolled.
Answer: small
⩥ Open-label trial
Answer: both the researchers and subjects know which treatment is
being administered
⩥ Single-blind trial
Answer: subjects are not aware of which treatment is administered,
researchers do know
⩥ therapeutic efficacy
, Answer: ability of a treatment (drug, therapy) to produce its intended
beneficial effects
⩥ Phase 2 trials primary objective
Answer: to explore therapeutic efficacy
⩥ Phase 3 trials primary objective
Answer: to demonstrate, or confirm therapeutic benefit
⩥ Phase 4 trials begin _________ drug approval by the FDA.
Answer: after
⩥ Phase 4 trials primary objective
Answer: to monitor the long-term safety, effectiveness, and optimal use
of an approved drug in the general population after approval, identifying
rare side effects or risks missed in earlier controlled studies, and
exploring new uses, doses, or combinations in real-world settings
⩥ PK Sampling
Answer: Involves collecting biological samples at specific times after
the drug is given to understand how the BODY absorbs, distributes,
metabolizes, and excretes it
