1|Page
ACRP CP FINAL EXAM LATEST 2026/2027 REAL
EXAM QUESTIONS AND CORRECT
ANSWERS|AGRADE
As part of a risk-based quality management approach, ICH GCP E6 (R2)
guidelines recommend that all of the following be included as risk
control measures EXCEPT what?
a. That the sponsor determines which risks to accept or reduce
b. That pre-defined quality tolerance limits (QLTs) are established
c. That quality tolerance limits (QLTs) are determined on an as needed
basis
d. That deviations from QLTs should trigger an evaluation to determine
if further action is needed. ......ANSWER......c. That quality tolerance
limits (QLTs) are determined on an as needed basis.
True or false?
According to local law, Investigators should immediately report SAEs to
the sponsors and IRB/IEC followed by detailed written reports within a
timely fashion. ......ANSWER......True
How can data quality assurance be ensured?
pg. 1
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a. Training of study personnel
b. Monitoring of investigators by sponsor/CRO personnel
c. Instruction manuals
d. Data verification
e. Centralized testing (e.g., labs, ECG readings)
f. All of the above
g. B and D only ......ANSWER......f. All of the above
A planned measurement described in the protocol that is used to
determine the effect of an intervention/treatment on participants is
called what?
1. An outcome measure
2. A primary objective
3. A hypothesis
4. None of the above ......ANSWER......1. An outcome measure
The sponsor should ensure oversight of any trial-related duties and
functions carried out on its behalf, including trial related duties and
functions that are subcontracted to another party by the sponsor's
contracted CRO(s).
pg. 2
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a. True
b. False
c. It depends on the level of risk associated with the trial
......ANSWER......a. True
Per the protocol, an ECG should be performed at Visit 2. At site #A123,
subject A-102 missed the visit due to a winter storm. The appointment
was rescheduled for a week later, although this was out of the protocol
visit window, and the ECG was performed at that time and revealed no
abnormalities. What is this an example of?
a. A major protocol deviation
b. A preventable protocol deviation
c. Serious misconduct but no protocol deviation
d. A protocol deviation that should be addressed via a note to file and
retraining
e. A protocol deviation that should be documented
f. A protocol deviation that should be reported to the IRB/IEC
......ANSWER......e. A protocol deviation that should be documented
All but which of the following have the authority to terminate a clinical
trial for the entire study or at a given site?
a. The sponsor
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b. The CRO
c. The IRB or IEC
d. The PI
e. IDMC or DSMB
f. The Regulatory Authorities
g. B and E ......ANSWER......g. B and E
True or false?
Deviations from standard medical practice are considered research.
......ANSWER......False
The nature and level of risk in a clinical trial could impact which of the
following?
a. Whether or not informed consent is required for the trial
b. Whether the IRB/IEC may review the progress of the trial more
frequently than every year
c. Whether the sponsor conducts any monitoring of the trial
d. All of the above ......ANSWER......b. Whether the IRB/IEC may review
the progress of the trial more frequently than every year
True or false?
pg. 4
ACRP CP FINAL EXAM LATEST 2026/2027 REAL
EXAM QUESTIONS AND CORRECT
ANSWERS|AGRADE
As part of a risk-based quality management approach, ICH GCP E6 (R2)
guidelines recommend that all of the following be included as risk
control measures EXCEPT what?
a. That the sponsor determines which risks to accept or reduce
b. That pre-defined quality tolerance limits (QLTs) are established
c. That quality tolerance limits (QLTs) are determined on an as needed
basis
d. That deviations from QLTs should trigger an evaluation to determine
if further action is needed. ......ANSWER......c. That quality tolerance
limits (QLTs) are determined on an as needed basis.
True or false?
According to local law, Investigators should immediately report SAEs to
the sponsors and IRB/IEC followed by detailed written reports within a
timely fashion. ......ANSWER......True
How can data quality assurance be ensured?
pg. 1
,2|Page
a. Training of study personnel
b. Monitoring of investigators by sponsor/CRO personnel
c. Instruction manuals
d. Data verification
e. Centralized testing (e.g., labs, ECG readings)
f. All of the above
g. B and D only ......ANSWER......f. All of the above
A planned measurement described in the protocol that is used to
determine the effect of an intervention/treatment on participants is
called what?
1. An outcome measure
2. A primary objective
3. A hypothesis
4. None of the above ......ANSWER......1. An outcome measure
The sponsor should ensure oversight of any trial-related duties and
functions carried out on its behalf, including trial related duties and
functions that are subcontracted to another party by the sponsor's
contracted CRO(s).
pg. 2
,3|Page
a. True
b. False
c. It depends on the level of risk associated with the trial
......ANSWER......a. True
Per the protocol, an ECG should be performed at Visit 2. At site #A123,
subject A-102 missed the visit due to a winter storm. The appointment
was rescheduled for a week later, although this was out of the protocol
visit window, and the ECG was performed at that time and revealed no
abnormalities. What is this an example of?
a. A major protocol deviation
b. A preventable protocol deviation
c. Serious misconduct but no protocol deviation
d. A protocol deviation that should be addressed via a note to file and
retraining
e. A protocol deviation that should be documented
f. A protocol deviation that should be reported to the IRB/IEC
......ANSWER......e. A protocol deviation that should be documented
All but which of the following have the authority to terminate a clinical
trial for the entire study or at a given site?
a. The sponsor
pg. 3
, 4|Page
b. The CRO
c. The IRB or IEC
d. The PI
e. IDMC or DSMB
f. The Regulatory Authorities
g. B and E ......ANSWER......g. B and E
True or false?
Deviations from standard medical practice are considered research.
......ANSWER......False
The nature and level of risk in a clinical trial could impact which of the
following?
a. Whether or not informed consent is required for the trial
b. Whether the IRB/IEC may review the progress of the trial more
frequently than every year
c. Whether the sponsor conducts any monitoring of the trial
d. All of the above ......ANSWER......b. Whether the IRB/IEC may review
the progress of the trial more frequently than every year
True or false?
pg. 4
