1
ACRP CCRC Exam Practice 2025 COMPLETE EXAM QUESTIONS
AND VERIFIED ANSWERS |RECENTLY TESTING REAL EXAM
QUESTIONS| 100% SOLVED!!
CCRC Exam Practice Questions
Domain I: Investigational Product Management (Questions 1–16)
1. A research coordinator receives a shipment of an investigational product (IP)
from the sponsor. The temperature monitor shows the shipment exceeded the
allowed range for the final two hours of transit. The sponsor’s manual states that
the IP should be quarantined if temperature deviations occur. What is the most
appropriate immediate action?
A) Dispense the IP to the subject as planned, because the excursion was only two
hours.
B) Record the excursion in the IP accountability log and quarantine the shipment
pending sponsor instruction.
C) Return the entire shipment to the sponsor immediately.
D) Place the shipment in the refrigerator and use it only for subjects who are not
considered at-risk.
: Correct Answer : B
Explanation: The IP must be quarantined and held for sponsor evaluation to
determine if stability or potency was compromised. Dispensing it without sponsor
authorization (A) violates GCP and could harm subjects. Returning the shipment
(C) without quarantine and documentation may destroy evidence needed for
root-cause analysis. Simply refrigerating it and making your own judgment (D) is
outside the coordinator’s authority and would be a serious protocol deviation.
2. A research coordinator is training a new pharmacy technician on IP
accountability. Which statement by the technician indicates
an incorrect understanding of IP management?
A) “If I have to destroy any unused IP, I must obtain sponsor approval before
doing so.”
pg. 1
,2
B) “The inventory log must be updated each time IP is received, dispensed, or
returned.”
C) “I can make a correction in the IP log by writing the new information over the
incorrect entry.”
D) “The study’s randomization code can only be broken in a medical emergency
when the subject’s safety requires it.”
: Correct Answer : C
Explanation: Corrections in an IP accountability log must follow ALCOA+
principles—the original entry must remain legible, the change must be
documented with a dated initials and an explanation, and no information should
be obliterated or overwritten. ❌ A is correct; sponsor approval is required
before destroying IP. ❌ B is correct; IP logs must be updated in real time for
each transaction. ❌ D is correct; unblinding should be avoided unless necessary
for subject safety, and the sponsor should be notified immediately after an
emergency unblinding.
3. A multicenter, double-blind trial has a high potential for unblinding because the
investigational product has a distinct taste. Which strategy should the coordinator
use to maintain blinding?
A) Use the same lot number for all IP for all subjects.
B) Dispense a placebo run-in for every subject.
C) Use a taste-masking additive in both the active and placebo preparations.
D) Instruct subjects not to discuss the taste with site staff.
: Correct Answer : C
Explanation: Adding a taste-masking additive to both the active product and the
placebo makes the two preparations indistinguishable, which preserves the
integrity of the blind. ❌ A doesn’t solve the taste issue. ❌ B (placebo run-in)
may help with adherence but does not mask the taste. ❌ D is an instruction, not
a procedural safeguard, and is not enforceable.
4. A coordinator notices that the temperature in the IP storage refrigerator has
fallen below the range specified in the pharmacy manual. What is the most
pg. 2
,3
appropriate initial step?
A) Move the IP to a different refrigerator and document the temperature
excursion.
B) Immediately discard all IP that was stored in that refrigerator.
C) Document the excursion, quarantine the affected IP, and contact the sponsor
for guidance.
D) Continue to use the IP because the temperature excursion was very brief.
: Correct Answer : C
Explanation: Any temperature excursion places the IP at risk of potency loss or
degradation. The coordinator must quarantine the affected IP, clearly label it as
“QUARANTINED,” and contact the sponsor for instructions. ❌ A (moving IP) does
not address the excursion. ❌ B (discarding IP) is premature and requires sponsor
approval. ❌ D (continuing to use the IP) disregards GCP and could harm
participants.
Domain II: Protocol Management (Questions 5–20)
5. A coordinator is asked to help a PI assess the feasibility of a new protocol at
their site. Which factor is most important to evaluate for successful enrollment?
A) The number of inclusion/exclusion criteria.
B) The size of the potential patient population at the site.
C) The level of reimbursements offered by the sponsor.
D) The number of non-English consent forms available.
: Correct Answer : B
Explanation: A site cannot enroll subjects if the appropriate patient population
does not exist. The potential patient pool must be assessed against the protocol’s
inclusion/exclusion criteria before any other feasibility considerations (staffing,
budget, etc.) can be evaluated. ❌ A is less important than the actual existence of
eligible patients. ❌ C (reimbursements) does not affect the ability to find eligible
patients. ❌ D (non-English consent forms) is important for a diverse population
but is not the primary determinant of enrollment feasibility.
pg. 3
, 4
6. A subject is admitted to the hospital for a serious adverse event (SAE) that is
possibly related to the investigational product. The subject’s spouse calls the site
and refuses to allow the coordinator to speak with the treating physician. What
should the coordinator do?
A) Respect the spouse’s request and wait for the subject to be discharged.
B) Explain that the sponsor requires SAE reports to be completed, regardless of
the spouse’s wishes.
C) Ask the spouse to put the subject’s attending physician on the line and attempt
to explain the situation.
D) Ask the principal investigator to call the subject’s attending physician directly.
: Correct Answer : C
Explanation: The coordinator should first try to communicate with the attending
physician directly. Once the physician understands that they are not being asked
to disclose protected information, they will usually cooperate. ❌ A (waiting for
discharge) would cause an unacceptable delay in SAE reporting. ❌ B (explaining
the requirement to the spouse) is unlikely to be productive and may worsen the
conflict. ❌ D involves the PI, but the coordinator should attempt to resolve the
issue themselves before escalating.
7. A study requires weekly pregnancy tests for all female subjects of childbearing
potential. The coordinator learns that a subject has had a positive result. What is
the most appropriate next step?
A) Immediately unblind the subject’s treatment assignment.
B) Instruct the subject to discontinue the IP and follow the protocol’s pregnancy
management section.
C) Report the positive result only to the IRB.
D) Wait for the sponsor to issue a pregnancy notification form before taking any
action.
: Correct Answer : B
Explanation: The protocol should include a specific section on pregnancy
management. The subject should be instructed to stop the IP immediately and
follow those instructions. ❌ A is premature; unblinding is not the first step
pg. 4
ACRP CCRC Exam Practice 2025 COMPLETE EXAM QUESTIONS
AND VERIFIED ANSWERS |RECENTLY TESTING REAL EXAM
QUESTIONS| 100% SOLVED!!
CCRC Exam Practice Questions
Domain I: Investigational Product Management (Questions 1–16)
1. A research coordinator receives a shipment of an investigational product (IP)
from the sponsor. The temperature monitor shows the shipment exceeded the
allowed range for the final two hours of transit. The sponsor’s manual states that
the IP should be quarantined if temperature deviations occur. What is the most
appropriate immediate action?
A) Dispense the IP to the subject as planned, because the excursion was only two
hours.
B) Record the excursion in the IP accountability log and quarantine the shipment
pending sponsor instruction.
C) Return the entire shipment to the sponsor immediately.
D) Place the shipment in the refrigerator and use it only for subjects who are not
considered at-risk.
: Correct Answer : B
Explanation: The IP must be quarantined and held for sponsor evaluation to
determine if stability or potency was compromised. Dispensing it without sponsor
authorization (A) violates GCP and could harm subjects. Returning the shipment
(C) without quarantine and documentation may destroy evidence needed for
root-cause analysis. Simply refrigerating it and making your own judgment (D) is
outside the coordinator’s authority and would be a serious protocol deviation.
2. A research coordinator is training a new pharmacy technician on IP
accountability. Which statement by the technician indicates
an incorrect understanding of IP management?
A) “If I have to destroy any unused IP, I must obtain sponsor approval before
doing so.”
pg. 1
,2
B) “The inventory log must be updated each time IP is received, dispensed, or
returned.”
C) “I can make a correction in the IP log by writing the new information over the
incorrect entry.”
D) “The study’s randomization code can only be broken in a medical emergency
when the subject’s safety requires it.”
: Correct Answer : C
Explanation: Corrections in an IP accountability log must follow ALCOA+
principles—the original entry must remain legible, the change must be
documented with a dated initials and an explanation, and no information should
be obliterated or overwritten. ❌ A is correct; sponsor approval is required
before destroying IP. ❌ B is correct; IP logs must be updated in real time for
each transaction. ❌ D is correct; unblinding should be avoided unless necessary
for subject safety, and the sponsor should be notified immediately after an
emergency unblinding.
3. A multicenter, double-blind trial has a high potential for unblinding because the
investigational product has a distinct taste. Which strategy should the coordinator
use to maintain blinding?
A) Use the same lot number for all IP for all subjects.
B) Dispense a placebo run-in for every subject.
C) Use a taste-masking additive in both the active and placebo preparations.
D) Instruct subjects not to discuss the taste with site staff.
: Correct Answer : C
Explanation: Adding a taste-masking additive to both the active product and the
placebo makes the two preparations indistinguishable, which preserves the
integrity of the blind. ❌ A doesn’t solve the taste issue. ❌ B (placebo run-in)
may help with adherence but does not mask the taste. ❌ D is an instruction, not
a procedural safeguard, and is not enforceable.
4. A coordinator notices that the temperature in the IP storage refrigerator has
fallen below the range specified in the pharmacy manual. What is the most
pg. 2
,3
appropriate initial step?
A) Move the IP to a different refrigerator and document the temperature
excursion.
B) Immediately discard all IP that was stored in that refrigerator.
C) Document the excursion, quarantine the affected IP, and contact the sponsor
for guidance.
D) Continue to use the IP because the temperature excursion was very brief.
: Correct Answer : C
Explanation: Any temperature excursion places the IP at risk of potency loss or
degradation. The coordinator must quarantine the affected IP, clearly label it as
“QUARANTINED,” and contact the sponsor for instructions. ❌ A (moving IP) does
not address the excursion. ❌ B (discarding IP) is premature and requires sponsor
approval. ❌ D (continuing to use the IP) disregards GCP and could harm
participants.
Domain II: Protocol Management (Questions 5–20)
5. A coordinator is asked to help a PI assess the feasibility of a new protocol at
their site. Which factor is most important to evaluate for successful enrollment?
A) The number of inclusion/exclusion criteria.
B) The size of the potential patient population at the site.
C) The level of reimbursements offered by the sponsor.
D) The number of non-English consent forms available.
: Correct Answer : B
Explanation: A site cannot enroll subjects if the appropriate patient population
does not exist. The potential patient pool must be assessed against the protocol’s
inclusion/exclusion criteria before any other feasibility considerations (staffing,
budget, etc.) can be evaluated. ❌ A is less important than the actual existence of
eligible patients. ❌ C (reimbursements) does not affect the ability to find eligible
patients. ❌ D (non-English consent forms) is important for a diverse population
but is not the primary determinant of enrollment feasibility.
pg. 3
, 4
6. A subject is admitted to the hospital for a serious adverse event (SAE) that is
possibly related to the investigational product. The subject’s spouse calls the site
and refuses to allow the coordinator to speak with the treating physician. What
should the coordinator do?
A) Respect the spouse’s request and wait for the subject to be discharged.
B) Explain that the sponsor requires SAE reports to be completed, regardless of
the spouse’s wishes.
C) Ask the spouse to put the subject’s attending physician on the line and attempt
to explain the situation.
D) Ask the principal investigator to call the subject’s attending physician directly.
: Correct Answer : C
Explanation: The coordinator should first try to communicate with the attending
physician directly. Once the physician understands that they are not being asked
to disclose protected information, they will usually cooperate. ❌ A (waiting for
discharge) would cause an unacceptable delay in SAE reporting. ❌ B (explaining
the requirement to the spouse) is unlikely to be productive and may worsen the
conflict. ❌ D involves the PI, but the coordinator should attempt to resolve the
issue themselves before escalating.
7. A study requires weekly pregnancy tests for all female subjects of childbearing
potential. The coordinator learns that a subject has had a positive result. What is
the most appropriate next step?
A) Immediately unblind the subject’s treatment assignment.
B) Instruct the subject to discontinue the IP and follow the protocol’s pregnancy
management section.
C) Report the positive result only to the IRB.
D) Wait for the sponsor to issue a pregnancy notification form before taking any
action.
: Correct Answer : B
Explanation: The protocol should include a specific section on pregnancy
management. The subject should be instructed to stop the IP immediately and
follow those instructions. ❌ A is premature; unblinding is not the first step
pg. 4
