ACRP Practice Exam Questions with Complete
Solutions 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%
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 - ANSWER AST 130; ALT; 70; BUN 50; Create 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? - ANSWER 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? -
ANSWER trial schedule of events
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, 1
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? - ANSWER 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? -
ANSWER 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? - ANSWER 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
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