ACRP CP FINAL EXAM LATEST 2023 REAL
EXAM 150 QUESTIONS AND CORRECT
ANSWERS|AGRADE
A subject is issued 120 tablets and is instructed to take 2 tablets
... [Show More] 4 times a day. He returns 88
tablets on the morning of day 9 fasting for laboratory tests. What percentcompliant is he? -
ANSWER 50%
To be eligible for a trial, the subjects must have liver function tests no greater than twotimes 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 thesubject? - 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 trialschedule
of events
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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 theCRC
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? - ANSWERReview 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 lastdose? -
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 ICFand is ready
to do the trial. He does not have a copy of the ICF that was mailed to his
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home with him. According to ICH Guidelines, which are the best actions for the CRC totake
initially? - ANSWER 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 labwill be closing in
1 hour. Which of the following is the MOST appropriate action for the CRC? - ANSWER 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 - ANSWER confidentiality agreement
If the patient's weight is 123 lb, what is the weight in kg? - ANSWER 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 whenthe CRA would like
to visit. The CRC should do which of the following? - ANSWER 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 30days, 60 months and
1 year.
At 30 days, protocol requires a physical exam, an ECG and chest xrayAt 6
months, physical and ECG
At 1 year, physical, ECG and chest xray [Show Less]