CRA ACRP UPDATED ACTUAL EXAM QUESTIONS CORRECT ANSWERS GRADED A PLUS
Question:
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:
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:
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:
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.
, Question:
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
Question:
If the patient's weight is 123 lb, what is the weight in kg?
Answer:
56
Question:
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.
Question:
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
Question:
Question:
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:
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:
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:
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.
, Question:
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
Question:
If the patient's weight is 123 lb, what is the weight in kg?
Answer:
56
Question:
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.
Question:
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
Question:
