ACRP CCRC EXAM UPDATED ACTUAL QUESTIONS AND
CORRECT ANSWERS
Question:
1. The DSMB has prematurely terminated a trial evaluating an investigational pain medication that is taken
one caplet orally
b.i.d. for chronic hip pain. Subjects are allowed to take one extra caplet per day. Subjects receive a
sufficient quantity of IP for 14 days plus two additional doses. Which of the following represents a drug
accountability issue?
Answer:
Subject B returns 12 pills after 8 days on the trial.
Question:
2. 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%
Question:
3. 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
Question:
4. 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
Question:
5. double-blind trial
Answer:
study where participants and the study team interacting with them (investigator, arc) are unaware of
treatment allocation
Question:
6. 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
, Question:
7. 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
Question:
8. Phase 1 trials typically have a ________ group of subjects enrolled.
Answer:
small
Question:
9. Open-label trial
Answer:
both the researchers and subjects know which treatment is being administered
Question:
10. Single-blind trial
Answer:
subjects are not aware of which treatment is administered, researchers do know
Question:
11. therapeutic efficacy
Answer:
ability of a treatment (drug, therapy) to produce its intended beneficial effects
Question:
12. Phase 2 trials primary objective
Answer:
to explore therapeutic efficacy
Question:
13. Phase 3 trials primary objective
Answer:
to demonstrate, or confirm therapeutic benefit
Question:
14. Phase 4 trials begin _________ drug approval by the FDA.
Answer:
after
Question:
15. Phase 4 trials primary objective
CORRECT ANSWERS
Question:
1. The DSMB has prematurely terminated a trial evaluating an investigational pain medication that is taken
one caplet orally
b.i.d. for chronic hip pain. Subjects are allowed to take one extra caplet per day. Subjects receive a
sufficient quantity of IP for 14 days plus two additional doses. Which of the following represents a drug
accountability issue?
Answer:
Subject B returns 12 pills after 8 days on the trial.
Question:
2. 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%
Question:
3. 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
Question:
4. 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
Question:
5. double-blind trial
Answer:
study where participants and the study team interacting with them (investigator, arc) are unaware of
treatment allocation
Question:
6. 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
, Question:
7. 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
Question:
8. Phase 1 trials typically have a ________ group of subjects enrolled.
Answer:
small
Question:
9. Open-label trial
Answer:
both the researchers and subjects know which treatment is being administered
Question:
10. Single-blind trial
Answer:
subjects are not aware of which treatment is administered, researchers do know
Question:
11. therapeutic efficacy
Answer:
ability of a treatment (drug, therapy) to produce its intended beneficial effects
Question:
12. Phase 2 trials primary objective
Answer:
to explore therapeutic efficacy
Question:
13. Phase 3 trials primary objective
Answer:
to demonstrate, or confirm therapeutic benefit
Question:
14. Phase 4 trials begin _________ drug approval by the FDA.
Answer:
after
Question:
15. Phase 4 trials primary objective
