ACRP Practice Exam
Study online at https://quizlet.com/_hj5g8k
1. Which of the following statements describes an ade- c. the effects of the IP can
quate and well-controlled trial? be addressed
a. The trial is closely monitored.
b. The IP meets GMP standards.
c. The effects of the IP can be assessed.
d. Source documentation is verified for all subjects.
2. Which of the following represents well-written inclu- d. 3 and 4 only
sion/exclusion criteria for an anti-hypertensive proto-
col?
1. satisfactory stress test
2. use of a Holter monitor
3. no previous history of stroke
4. Diastolic blood pressure greater than 100
a. 1 and 2 only
b. 1 and 3 only
c. 2 and 4 only
d. 3 and 4 only
3. Intent-to-treat trial data analysis only includes subjects c. randomized
who were ________________.
a. screened.
b. completed.
c. randomized.
d. discontinued.
4. A trial protocol amendment is required if there is: c. an increase in the sam-
a replacement of a site. ple size.
b. a site investigator change.
c. an increase in the sample size.
d. a merger involving the sponsor.
, ACRP Practice Exam
Study online at https://quizlet.com/_hj5g8k
5. In a double-blind trial comparing IP A to IP B, the a.1680 IP; 4800 IP
treatment will be either q.d. x 7 days on IP A or b.i.d.
x 10 days on IP B (1:1). The countries participating will
be the US, Canada, Mexico, and the UK. The US has
been allocated 2 times more subjects than each other
country. The trial needs 2000 subjects, and in order to
make sure there is a sufficient supply, the sponsor will
add a supply overage of 20%. For Canada, how many
capsules of each product will need to be produced for
this trial?
a.1680 IP; 4800 IP
b.3360 IP; 9600 IP
c.2800 IP; 8000 IP
d. 8400 IP; 24,000 IP
6. When choosing a CRO to manage a clinical trial, which b. 1 and 4 only
of the following are required by ICH Guidelines?1.
Transfer of responsibilities must be documented in
writing.2. Responsibilities transferred to the CRO be-
come the ultimate responsibility of the CRO.3. A spon-
sor must transfer all of the responsibilities to one
CRO.4. Obligations not described in any written agree-
ment shall be deemed not to have transferred.
a. 1 and 3 only
b. 1 and 4 only
c. 2 and 3 only
d. 2 and 4 only
7. A CRA is preparing a budget for a migraine trial. The c. $894
trial will include two visits with physical exams and the
CRC will be at both visits. There will be an ECG and
blood draw at visit 1. Using the fees below, what is the
, ACRP Practice Exam
Study online at https://quizlet.com/_hj5g8k
charge per subject?
Physical exam = $200
CRC = $75
Blood draw = $20
ECG = $75
Total subject stipend = $100
Overhead (on final budget) = 20%
a. $745
b. $774
c. $894
d. $1014
8. The BEST recommendation for a potential investigator d. 3 and 4 only
in a Phase III diabetic clinical trial is a physician who
has:
1. a private practice with a limited patient base.
2. high interest, but little time for clinical trials.
3. applied for a board certification in endocrinology.
4. received an inspection report 5 years ago citing
missing SOPs.
a. 1 and 2 only
b. 1 and 3 only
c. 2 and 4 only
d. 3 and 4 only
9. The schedule of monitoring visits is determined by d. 3 and 4 only
the:
1. ICH Guidelines.
2. regulatory submission guidelines.
3. protocol complexity.
4. rate of enrollment.
Study online at https://quizlet.com/_hj5g8k
1. Which of the following statements describes an ade- c. the effects of the IP can
quate and well-controlled trial? be addressed
a. The trial is closely monitored.
b. The IP meets GMP standards.
c. The effects of the IP can be assessed.
d. Source documentation is verified for all subjects.
2. Which of the following represents well-written inclu- d. 3 and 4 only
sion/exclusion criteria for an anti-hypertensive proto-
col?
1. satisfactory stress test
2. use of a Holter monitor
3. no previous history of stroke
4. Diastolic blood pressure greater than 100
a. 1 and 2 only
b. 1 and 3 only
c. 2 and 4 only
d. 3 and 4 only
3. Intent-to-treat trial data analysis only includes subjects c. randomized
who were ________________.
a. screened.
b. completed.
c. randomized.
d. discontinued.
4. A trial protocol amendment is required if there is: c. an increase in the sam-
a replacement of a site. ple size.
b. a site investigator change.
c. an increase in the sample size.
d. a merger involving the sponsor.
, ACRP Practice Exam
Study online at https://quizlet.com/_hj5g8k
5. In a double-blind trial comparing IP A to IP B, the a.1680 IP; 4800 IP
treatment will be either q.d. x 7 days on IP A or b.i.d.
x 10 days on IP B (1:1). The countries participating will
be the US, Canada, Mexico, and the UK. The US has
been allocated 2 times more subjects than each other
country. The trial needs 2000 subjects, and in order to
make sure there is a sufficient supply, the sponsor will
add a supply overage of 20%. For Canada, how many
capsules of each product will need to be produced for
this trial?
a.1680 IP; 4800 IP
b.3360 IP; 9600 IP
c.2800 IP; 8000 IP
d. 8400 IP; 24,000 IP
6. When choosing a CRO to manage a clinical trial, which b. 1 and 4 only
of the following are required by ICH Guidelines?1.
Transfer of responsibilities must be documented in
writing.2. Responsibilities transferred to the CRO be-
come the ultimate responsibility of the CRO.3. A spon-
sor must transfer all of the responsibilities to one
CRO.4. Obligations not described in any written agree-
ment shall be deemed not to have transferred.
a. 1 and 3 only
b. 1 and 4 only
c. 2 and 3 only
d. 2 and 4 only
7. A CRA is preparing a budget for a migraine trial. The c. $894
trial will include two visits with physical exams and the
CRC will be at both visits. There will be an ECG and
blood draw at visit 1. Using the fees below, what is the
, ACRP Practice Exam
Study online at https://quizlet.com/_hj5g8k
charge per subject?
Physical exam = $200
CRC = $75
Blood draw = $20
ECG = $75
Total subject stipend = $100
Overhead (on final budget) = 20%
a. $745
b. $774
c. $894
d. $1014
8. The BEST recommendation for a potential investigator d. 3 and 4 only
in a Phase III diabetic clinical trial is a physician who
has:
1. a private practice with a limited patient base.
2. high interest, but little time for clinical trials.
3. applied for a board certification in endocrinology.
4. received an inspection report 5 years ago citing
missing SOPs.
a. 1 and 2 only
b. 1 and 3 only
c. 2 and 4 only
d. 3 and 4 only
9. The schedule of monitoring visits is determined by d. 3 and 4 only
the:
1. ICH Guidelines.
2. regulatory submission guidelines.
3. protocol complexity.
4. rate of enrollment.
