ACRP
Practice
Exam 2023
Questions
and Correct
Answers
, 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 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
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
Practice
Exam 2023
Questions
and Correct
Answers
, 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 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
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
