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ACRP Practice Exam: Questions With Correct Solutions
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ACRP Practice Exam: Questions With Correct Solutions
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ACRP Practice Exam: Questions WithCorrect Solutions
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? - -50%
-To be eligible for a trial, the subjects must have liver function tests no
greater than two times the upper limit normal and rental function tests no
greater than three times the upper limit normal. All of the following are
normal ranges for the trial:
AST 5-65
ALT 5-35
BUN 4-25
Creat 0.5-1.2
Amylase 56-190
Lipase 4-24
ALK Phos 0-110 - -AST 130; ALT; 70; BUN 50; Creat 2.4
-A subject presents at a site with her husband after pre-qualifying on a
phone screen. She states that she is legally blind and cannot read the ICF. A
Braille ICF is not available. This subject is able to sign her name if her hand is
guided to the signature line. Which of the following is the BEST course of
action to obtain legal consent from the subject? - -The subject and an
impartial witness can sign the ICF after it is read to them and she verbally
states her understanding.
-Which of the following is MOST useful for scheduling trial procedures? - -
trial schedule of events
-A subject is participating in a clinical trial where only the pharmacist and
sponsor knows the identity of the IP. The pharmacist has no contact with the
trial subject and the clinical team. Which of the following BEST describes this
trial type? - -double blind
-A site has not received IRB/IEC approval for a protocol submission. The PI
instructs the CRC employed by the clinic to begin scheduling subjects for
screening appointments. Which of the following is the BEST course of action
for the CRC to take? - -Review the research database and collate a list of
potential subjects
-The trough blood level for once daily drug should be drawn how long after
the last dose? - -24 hours
, -A potential subject for a trial has been mailed an ICF prior to his screening
visit. When the subject arrives at the research dept for his screening visit, he
states he read the ICF and is ready to do the trial. He does not have a copy
of the ICF that was mailed to his home with him. According to ICH Guidelines,
which are the best actions for the CRC to take initially? - -Have the subject
sign the ICF
Confirm the subject's understanding of the ICF
-A CRC is enrolling three subjects for a Phase III trial with restrictive
eligibility criteria. The PI indicates that she must leave the office to teach a
lecture in 30 minutes. The lab will be closing in 1 hour. Which of the following
is the MOST appropriate action for the CRC? - -Give each subject sufficient
time to review the ICF
-All of the following are regulatory documents except:
informed consent
protocol signature page
lab certification
confidentiality agreement - -confidentiality agreement
-If the patient's weight is 123 lb, what is the weight in kg? - -56
-A CRA calls to schedule a close-out visit. Per sponsor SOPs, the PI must be
present. The CRC informs the CRA That the PI will be out of the country
during the period when the CRA would like to visit. The CRC should do which
of the following? - -Reschedule the close-out visit for a later date
-The CRC reviewed a new protocol to prepare the trial budget for submission
to the sponsor. According to the protocol, each subject is to return for follow
up visits at 30 days, 60 months and 1 year.
At 30 days, protocol requires a physical exam, an ECG and chest xray
At 6 months, physical and ECG
At 1 year, physical, ECG and chest xray
The hospital charges $75 for the physical exam, $50 for the ECG and $100
for chest xray. The 30day and 1year visits are SOC for the subjects. How
much should the CRC budget for the non-SOC visits? - -$125
-According to ICH guidelines, the source document should contain which of
the following information regarding informed consent? - -Evidence that the
consent form was signed prior to trial related procedures
-A subject has signed the informed consent form for a hypertenstion trial. All
screening procedures and the physical examination have been completed.
The CRC is ready to dispense the single-blind placebo to the subject who
asks "Is that the sugar pill I read about in that form I signed?" Which of the
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