ACRP CCRA EXAM ACTUAL EXAM 2026 | ASSOCIATION OF CLINICAL
RESEARCH PROFESSIONALS (ACRP) CERTIFIED CLINICAL RESEARCH
ASSOCIATE EXAM | UPDATED VERSION | JUST RELEASED
Question 1
What are expected or possible consequences of over-estimating patient recruitment potential
for a clinical trial? (Select all that apply)
A) The trial will overrun its projected timeline.
B) The recruitment period will be prolonged, and more sites may be needed.
C) The study will not have sufficient data and may be stopped due to lack of budget.
D) The trial will finish ahead of schedule.
E) The study drug will be approved faster.
Correct Answer: A) The trial will overrun its projected timeline., B) The recruitment period will
be prolonged, and more sites may be needed., C) The study will not have sufficient data and
may be stopped due to lack of budget.
Rationale: Over-estimation of recruitment leads to delays as the site struggles to enroll the
promised number of subjects. This prolongs timelines, increases costs (potentially requiring
more sites to be added), and risks the trial failing to gather enough data before the budget is
exhausted.
Question 2
What should be the first and most important consideration when conducting a clinical trial?
A) Data integrity
B) Subject welfare
C) Adherence to the protocol
D) The budget
E) The timeline
Correct Answer: B) Subject welfare
Rationale: According to all major ethical guidelines (including ICH GCP, the Belmont Report,
and the Declaration of Helsinki), the rights, safety, and well-being of the trial subjects are the
most important consideration and should prevail over the interests of science and society.
,Question 3
When is an investigator allowed to deviate from the protocol without prior approval from the
sponsor and IRB/IEC?
A) When a subject requests a different dose of the study drug.
B) When the investigator believes it will produce better data.
C) When there is an immediate hazard to a patient.
D) When the study coordinator is unavailable to perform a required procedure.
E) Never, under any circumstances.
Correct Answer: C) When there is an immediate hazard to a patient.
Rationale: ICH GCP allows for a protocol deviation without prior approval only when it is
necessary to eliminate an immediate hazard to a trial subject. In all other cases, the protocol
must be followed exactly.
Question 4
If an investigator deviates from the protocol to eliminate an immediate hazard to a patient,
according to ICH E6 guidelines, who must they report the deviation and rationale to, when
appropriate? (Select all that apply)
A) The Sponsor
B) The IRB/IEC
C) The Regulatory Authorities
D) The subject's primary care physician
E) The hospital's risk management department
Correct Answer: A) The Sponsor, B) The IRB/IEC, C) The Regulatory Authorities
Rationale: ICH E6 4.5.2 and 4.5.4 state that the investigator should document the deviation
and its reasons and, as soon as possible, submit the deviation to the sponsor, the IRB/IEC for
review and approval/favorable opinion, and to regulatory authorities if required.
Question 5
Which conditions must be fulfilled before enrolling a subject into a clinical trial? (Select all that
apply)
,A) The subject meets all inclusion criteria.
B) The subject has given written informed consent.
C) The investigator believes the subject will be compliant.
D) The sponsor has pre-approved the subject for enrollment.
E) The subject has paid their portion of the trial costs.
Correct Answer: A) The subject meets all inclusion criteria., B) The subject has given written
informed consent.
Rationale: These are the two fundamental requirements for enrollment. The subject must be
eligible for the trial based on the protocol's inclusion/exclusion criteria, and they must have
voluntarily agreed to participate by signing the informed consent form before any trial-related
procedures are performed.
Question 6
The IP storage room temperature log failed over the weekend. The IP must be stored below
25°C. On Monday morning, the current temperature is 24°C. What should you do? (Select all
that apply)
A) Assume the temperature was stable and do nothing.
B) Contact the Sponsor, explain what happened, and ask for instructions.
C) Quarantine the affected IP until you receive instructions.
D) Calibrate a new temperature monitoring device immediately.
E) Set up a site staff meeting to conduct a root cause analysis.
Correct Answer: B) Contact the Sponsor, explain what happened, and ask for instructions.,
C) Quarantine the affected IP until you receive instructions.
Rationale: Since the temperature over the weekend is unknown, the integrity of the
Investigational Product (IP) may have been compromised. The correct action is to immediately
quarantine the IP to prevent it from being dispensed and to contact the sponsor to report the
temperature excursion and await their instructions on whether the IP is still usable.
Question 7
A protocol amendment increases the IP dose. You have IRB approval. You re-consent subjects
, still taking the IP but not those who have completed their drug intake period. Is this allowed
under GCP?
A) Yes, because they are no longer receiving the IP, the change does not affect them.
B) No, these subjects are still enrolled in the trial and therefore need to be updated on any
changes to the protocol.
C) Yes, as long as the sponsor agrees with this approach.
D) No, but you can inform them with a letter instead of re-consenting them.
E) Yes, because re-consenting them would be an unnecessary burden.
Correct Answer: B) No, these subjects are still enrolled in the trial and therefore need to be
updated on any changes to the protocol.
Rationale: Informed consent is an ongoing process. As long as a subject is still participating in
a trial (e.g., in the follow-up phase), they must be informed of any new information that
might affect their willingness to continue participation. All active subjects, regardless of their
IP status, must be re-consented with the revised ICF.
Question 8
A trial subject informs you she no longer wants to participate in the trial. What should your
course of action be?
A) Tell the subject she cannot withdraw until she completes the final study visit.
B) Immediately cross out all of the subject's data from the source documents.
C) You ask if the subject wishes to share the reason for her withdrawal. If not, you document
her withdrawal and end her participation immediately.
D) Inform the subject that her decision will affect her future medical care at your institution.
E) Insist that the subject provide a detailed reason for her withdrawal for the study record.
Correct Answer: C) You ask if the subject wishes to share the reason for her withdrawal. If not,
you document her withdrawal and end her participation immediately.
Rationale: A subject has the right to withdraw from a trial at any time for any reason. The site
should respect this right without prejudice. While it is helpful for the study to understand the
RESEARCH PROFESSIONALS (ACRP) CERTIFIED CLINICAL RESEARCH
ASSOCIATE EXAM | UPDATED VERSION | JUST RELEASED
Question 1
What are expected or possible consequences of over-estimating patient recruitment potential
for a clinical trial? (Select all that apply)
A) The trial will overrun its projected timeline.
B) The recruitment period will be prolonged, and more sites may be needed.
C) The study will not have sufficient data and may be stopped due to lack of budget.
D) The trial will finish ahead of schedule.
E) The study drug will be approved faster.
Correct Answer: A) The trial will overrun its projected timeline., B) The recruitment period will
be prolonged, and more sites may be needed., C) The study will not have sufficient data and
may be stopped due to lack of budget.
Rationale: Over-estimation of recruitment leads to delays as the site struggles to enroll the
promised number of subjects. This prolongs timelines, increases costs (potentially requiring
more sites to be added), and risks the trial failing to gather enough data before the budget is
exhausted.
Question 2
What should be the first and most important consideration when conducting a clinical trial?
A) Data integrity
B) Subject welfare
C) Adherence to the protocol
D) The budget
E) The timeline
Correct Answer: B) Subject welfare
Rationale: According to all major ethical guidelines (including ICH GCP, the Belmont Report,
and the Declaration of Helsinki), the rights, safety, and well-being of the trial subjects are the
most important consideration and should prevail over the interests of science and society.
,Question 3
When is an investigator allowed to deviate from the protocol without prior approval from the
sponsor and IRB/IEC?
A) When a subject requests a different dose of the study drug.
B) When the investigator believes it will produce better data.
C) When there is an immediate hazard to a patient.
D) When the study coordinator is unavailable to perform a required procedure.
E) Never, under any circumstances.
Correct Answer: C) When there is an immediate hazard to a patient.
Rationale: ICH GCP allows for a protocol deviation without prior approval only when it is
necessary to eliminate an immediate hazard to a trial subject. In all other cases, the protocol
must be followed exactly.
Question 4
If an investigator deviates from the protocol to eliminate an immediate hazard to a patient,
according to ICH E6 guidelines, who must they report the deviation and rationale to, when
appropriate? (Select all that apply)
A) The Sponsor
B) The IRB/IEC
C) The Regulatory Authorities
D) The subject's primary care physician
E) The hospital's risk management department
Correct Answer: A) The Sponsor, B) The IRB/IEC, C) The Regulatory Authorities
Rationale: ICH E6 4.5.2 and 4.5.4 state that the investigator should document the deviation
and its reasons and, as soon as possible, submit the deviation to the sponsor, the IRB/IEC for
review and approval/favorable opinion, and to regulatory authorities if required.
Question 5
Which conditions must be fulfilled before enrolling a subject into a clinical trial? (Select all that
apply)
,A) The subject meets all inclusion criteria.
B) The subject has given written informed consent.
C) The investigator believes the subject will be compliant.
D) The sponsor has pre-approved the subject for enrollment.
E) The subject has paid their portion of the trial costs.
Correct Answer: A) The subject meets all inclusion criteria., B) The subject has given written
informed consent.
Rationale: These are the two fundamental requirements for enrollment. The subject must be
eligible for the trial based on the protocol's inclusion/exclusion criteria, and they must have
voluntarily agreed to participate by signing the informed consent form before any trial-related
procedures are performed.
Question 6
The IP storage room temperature log failed over the weekend. The IP must be stored below
25°C. On Monday morning, the current temperature is 24°C. What should you do? (Select all
that apply)
A) Assume the temperature was stable and do nothing.
B) Contact the Sponsor, explain what happened, and ask for instructions.
C) Quarantine the affected IP until you receive instructions.
D) Calibrate a new temperature monitoring device immediately.
E) Set up a site staff meeting to conduct a root cause analysis.
Correct Answer: B) Contact the Sponsor, explain what happened, and ask for instructions.,
C) Quarantine the affected IP until you receive instructions.
Rationale: Since the temperature over the weekend is unknown, the integrity of the
Investigational Product (IP) may have been compromised. The correct action is to immediately
quarantine the IP to prevent it from being dispensed and to contact the sponsor to report the
temperature excursion and await their instructions on whether the IP is still usable.
Question 7
A protocol amendment increases the IP dose. You have IRB approval. You re-consent subjects
, still taking the IP but not those who have completed their drug intake period. Is this allowed
under GCP?
A) Yes, because they are no longer receiving the IP, the change does not affect them.
B) No, these subjects are still enrolled in the trial and therefore need to be updated on any
changes to the protocol.
C) Yes, as long as the sponsor agrees with this approach.
D) No, but you can inform them with a letter instead of re-consenting them.
E) Yes, because re-consenting them would be an unnecessary burden.
Correct Answer: B) No, these subjects are still enrolled in the trial and therefore need to be
updated on any changes to the protocol.
Rationale: Informed consent is an ongoing process. As long as a subject is still participating in
a trial (e.g., in the follow-up phase), they must be informed of any new information that
might affect their willingness to continue participation. All active subjects, regardless of their
IP status, must be re-consented with the revised ICF.
Question 8
A trial subject informs you she no longer wants to participate in the trial. What should your
course of action be?
A) Tell the subject she cannot withdraw until she completes the final study visit.
B) Immediately cross out all of the subject's data from the source documents.
C) You ask if the subject wishes to share the reason for her withdrawal. If not, you document
her withdrawal and end her participation immediately.
D) Inform the subject that her decision will affect her future medical care at your institution.
E) Insist that the subject provide a detailed reason for her withdrawal for the study record.
Correct Answer: C) You ask if the subject wishes to share the reason for her withdrawal. If not,
you document her withdrawal and end her participation immediately.
Rationale: A subject has the right to withdraw from a trial at any time for any reason. The site
should respect this right without prejudice. While it is helpful for the study to understand the
