ACRP CCRC EXAM PREP BUNDLED
2026 CLINICAL TEST PAPER
QUESTIONS ANSWERS GRADED A+
◉ 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
◉ A small biotech company is investigating the anti-tumoral potential of
scorpion toxin in high grade recurrent brain tumors. After animal trials
have been completed, the first trial in humans would MOST likely
involve: Answer: healthy volunteers and dose escalation
◉ Phase 1 trials are primarily involved with ____ sampling. Answer: PK
◉ If the patient's weight is 123 lb, what is the weight in kg? Answer: 56
◉ Converting from lbs to kgs Answer: 1 lb = 0.453592 kgs
◉ In an effort to increase enrollment in an ongoing trial, the sponsor has
broadened inclusion/exclusion criteria to increase the allowable
creatinine level. The next step the CRC should take is to Answer: notify
the IRB/IEC of the change.
2026 CLINICAL TEST PAPER
QUESTIONS ANSWERS GRADED A+
◉ 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
◉ A small biotech company is investigating the anti-tumoral potential of
scorpion toxin in high grade recurrent brain tumors. After animal trials
have been completed, the first trial in humans would MOST likely
involve: Answer: healthy volunteers and dose escalation
◉ Phase 1 trials are primarily involved with ____ sampling. Answer: PK
◉ If the patient's weight is 123 lb, what is the weight in kg? Answer: 56
◉ Converting from lbs to kgs Answer: 1 lb = 0.453592 kgs
◉ In an effort to increase enrollment in an ongoing trial, the sponsor has
broadened inclusion/exclusion criteria to increase the allowable
creatinine level. The next step the CRC should take is to Answer: notify
the IRB/IEC of the change.
