ACRP CCRC EXAM PREP BUNDLED
2026 RESEARCH SCRIPT SOLVED
QUESTIONS VERIFIED ANSWERS 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
◉ 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 I trial.
◉ 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
1. healthy volunteers.
, 2. pharmacokinetic analysis.
3. placebo control.
4. dose escalation. Answer: 2 and 4 only
◉ If the patient's weight is 123 lb, what is the weight in kg? Answer: 56
◉ 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.
◉ A subject is participating in a lipid-lowering clinical trial. Before his
12-month visit, the CRC receives an amendment from the sponsor that
includes an outcomes measurement instrument at the 12-month visit.
The CRC should FIRST provide the subject with which of the
following? Answer: A revised consent form
◉ The protocol and protocol summary have been submitted to a central
IRB/IEC for review/approval by the CRO prior to the investigators'
meeting. Following the meeting, the entry criteria are altered to facilitate
the recruitment and retention of eligible subjects. Prior to trial start-up,
the regulatory binder must include:
1. an IRB/IEC letter of approval for the amended protocol
2. an IRB/IEC site evaluation form
3. the amended protocol
4. the Investigator's Brochure Answer: 1, 3, and 4 only
2026 RESEARCH SCRIPT SOLVED
QUESTIONS VERIFIED ANSWERS 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
◉ 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 I trial.
◉ 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
1. healthy volunteers.
, 2. pharmacokinetic analysis.
3. placebo control.
4. dose escalation. Answer: 2 and 4 only
◉ If the patient's weight is 123 lb, what is the weight in kg? Answer: 56
◉ 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.
◉ A subject is participating in a lipid-lowering clinical trial. Before his
12-month visit, the CRC receives an amendment from the sponsor that
includes an outcomes measurement instrument at the 12-month visit.
The CRC should FIRST provide the subject with which of the
following? Answer: A revised consent form
◉ The protocol and protocol summary have been submitted to a central
IRB/IEC for review/approval by the CRO prior to the investigators'
meeting. Following the meeting, the entry criteria are altered to facilitate
the recruitment and retention of eligible subjects. Prior to trial start-up,
the regulatory binder must include:
1. an IRB/IEC letter of approval for the amended protocol
2. an IRB/IEC site evaluation form
3. the amended protocol
4. the Investigator's Brochure Answer: 1, 3, and 4 only
