ACRP Practice Exam 2023-2024 Questions and Answers
100% Verified
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 following
should the CRC tell the subject?
"It might be placebo, but we will be checking your blood pressure every week"
At the month 3 visit of a Phase III double-blind trial, the subject informs the CRC
that he was seen in the emergency department for an anaphylactic reaction. The
subject states "The doctor told me i was very lucky. I might have died". Having
received this information, the MOST appropriate sequence of action is to inform
the:
PI, sponsor and IRB
100% Verified
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 following
should the CRC tell the subject?
"It might be placebo, but we will be checking your blood pressure every week"
At the month 3 visit of a Phase III double-blind trial, the subject informs the CRC
that he was seen in the emergency department for an anaphylactic reaction. The
subject states "The doctor told me i was very lucky. I might have died". Having
received this information, the MOST appropriate sequence of action is to inform
the:
PI, sponsor and IRB
