ACRP CCRA EXAM SET 2025/2026 COMPREHENSIVE
QUESTIONS AND ANSWERS FOR CERTIFICATION
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ACRP CCRA® Practice Exam: 100 Questions & Answers
Domain 1: Ethical and Participant Safety Considerations
1. The primary international ethical standard for clinical research involving
human subjects is:
A. The Declaration of Geneva
B. The Belmont Report
C. ✔ The International Council for Harmonisation Good Clinical Practice (ICH-GCP)
E6(R2)
D. The Hippocratic Oath
2. Which of the following is NOT a core principle outlined in The Belmont
Report?
A. Respect for Persons
B. Justice
C. Beneficence
D. ✔ Scientific Validity
3. The purpose of informed consent is to:
A. Protect the institution from liability.
B. ✔ Ensure the participant understands the trial and voluntarily agrees to
participate.
C. Obtain a signature on a legally binding document.
D. Fulfill a regulatory requirement for the FDA.
4. According to ICH-GCP, who has the ultimate responsibility for the conduct of a
trial at an investigative site?
A. The Clinical Research Coordinator (CRC)
,B. The Sponsor
C. ✔ The Principal Investigator (PI)
D. The Institutional Review Board (IRB)
5. An IRB/IEC must have at least how many members?
A. 3
B. ✔ 5
C. 7
D. 10
6. A potential participant who is illiterate is presented for enrollment. How
should the informed consent process be handled?
A. They cannot be enrolled in the study.
B. ✔ An impartial witness should be present for the entire oral consent process
and sign the consent form.
C. A family member can sign the consent form on their behalf.
D. Only a verbal consent is required, documented in the source.
7. When a participant experiences an unplanned pregnancy during a trial, the
first action should be to:
A. Terminate the participant from the study immediately.
B. Report it as an SAE within 24 hours.
C. ✔ Inform the PI and follow the protocol-defined procedures, which may include
discontinuing study treatment.
D. Notify the sponsor's medical monitor.
8. The primary role of a Data and Safety Monitoring Board (DSMB) is to:
A. Manage the study budget.
B. ✔ Periodically review accumulating trial data for participant safety and efficacy.
C. Conduct source data verification.
D. Write the clinical study report.
9. A protocol deviation is best defined as:
A. ✔ Any change, divergence, or departure from the study design or procedures
defined in the protocol.
,B. An unintentional error that has no impact on participant safety.
C. A violation that affects data integrity.
D. An action that requires reporting to the FDA within 10 days.
10. Vulnerable populations in clinical research may include all of the following
EXCEPT:
A. Prisoners
B. Pregnant women
C. ✔ Healthy volunteers
D. Individuals with cognitive impairments
Domain 2: Investigational Product Development and Regulation
11. What is the primary focus of a Phase I clinical trial?
A. Efficacy in a patient population
B. ✔ Safety, tolerability, and pharmacokinetics in a small number of subjects
(often healthy volunteers)
C. Comparative effectiveness against standard of care
D. Long-term safety and overall survival
12. The document that contains the compiled clinical and non-clinical data on an
investigational product to support its marketing approval is the:
A. Clinical Study Report (CSR)
B. Investigator's Brochure (IB)
C. ✔ Common Technical Document (CTD)
D. Protocol
13. The "investigational product" in a clinical trial can be:
A. A drug
B. A biologic
C. A device
D. ✔ All of the above
, 14. The FDA's 21 CFR Part 11 primarily addresses:
A. Financial disclosure by investigators.
B. ✔ Electronic records and electronic signatures.
C. Informed consent requirements.
D. IND safety reporting.
15. An amendment to an Investigational New Drug (IND) application is required
for:
A. Any change to the protocol.
B. ✔ Any change that significantly affects the safety, scope, or scientific quality of
the investigation.
C. Any change to the Investigator's Brochure.
D. All protocol deviations.
16. The purpose of a Clinical Trial Application (CTA) in the EU is analogous to
what in the US?
A. The Institutional Review Board (IRB) submission
B. ✔ The Investigational New Drug (IND) application
C. The New Drug Application (NDA)
D. The Investigator's Brochure (IB)
17. According to ICH-GCP, who is responsible for the accuracy and validity of the
data reported in the Case Report Form (CRF)?
A. The Sponsor (CRA)
B. The Data Management Team
C. ✔ The Investigator
D. The IRB/IEC
18. What is the primary purpose of a pre-study site selection visit?
A. To train the site staff.
B. To review source documents for enrolled participants.
C. ✔ To assess the site's capability and resources to conduct the trial.
D. To close out the study.
QUESTIONS AND ANSWERS FOR CERTIFICATION
SUCCESS || 100% GUARANTEED PASS <LATEST
VERSION>
ACRP CCRA® Practice Exam: 100 Questions & Answers
Domain 1: Ethical and Participant Safety Considerations
1. The primary international ethical standard for clinical research involving
human subjects is:
A. The Declaration of Geneva
B. The Belmont Report
C. ✔ The International Council for Harmonisation Good Clinical Practice (ICH-GCP)
E6(R2)
D. The Hippocratic Oath
2. Which of the following is NOT a core principle outlined in The Belmont
Report?
A. Respect for Persons
B. Justice
C. Beneficence
D. ✔ Scientific Validity
3. The purpose of informed consent is to:
A. Protect the institution from liability.
B. ✔ Ensure the participant understands the trial and voluntarily agrees to
participate.
C. Obtain a signature on a legally binding document.
D. Fulfill a regulatory requirement for the FDA.
4. According to ICH-GCP, who has the ultimate responsibility for the conduct of a
trial at an investigative site?
A. The Clinical Research Coordinator (CRC)
,B. The Sponsor
C. ✔ The Principal Investigator (PI)
D. The Institutional Review Board (IRB)
5. An IRB/IEC must have at least how many members?
A. 3
B. ✔ 5
C. 7
D. 10
6. A potential participant who is illiterate is presented for enrollment. How
should the informed consent process be handled?
A. They cannot be enrolled in the study.
B. ✔ An impartial witness should be present for the entire oral consent process
and sign the consent form.
C. A family member can sign the consent form on their behalf.
D. Only a verbal consent is required, documented in the source.
7. When a participant experiences an unplanned pregnancy during a trial, the
first action should be to:
A. Terminate the participant from the study immediately.
B. Report it as an SAE within 24 hours.
C. ✔ Inform the PI and follow the protocol-defined procedures, which may include
discontinuing study treatment.
D. Notify the sponsor's medical monitor.
8. The primary role of a Data and Safety Monitoring Board (DSMB) is to:
A. Manage the study budget.
B. ✔ Periodically review accumulating trial data for participant safety and efficacy.
C. Conduct source data verification.
D. Write the clinical study report.
9. A protocol deviation is best defined as:
A. ✔ Any change, divergence, or departure from the study design or procedures
defined in the protocol.
,B. An unintentional error that has no impact on participant safety.
C. A violation that affects data integrity.
D. An action that requires reporting to the FDA within 10 days.
10. Vulnerable populations in clinical research may include all of the following
EXCEPT:
A. Prisoners
B. Pregnant women
C. ✔ Healthy volunteers
D. Individuals with cognitive impairments
Domain 2: Investigational Product Development and Regulation
11. What is the primary focus of a Phase I clinical trial?
A. Efficacy in a patient population
B. ✔ Safety, tolerability, and pharmacokinetics in a small number of subjects
(often healthy volunteers)
C. Comparative effectiveness against standard of care
D. Long-term safety and overall survival
12. The document that contains the compiled clinical and non-clinical data on an
investigational product to support its marketing approval is the:
A. Clinical Study Report (CSR)
B. Investigator's Brochure (IB)
C. ✔ Common Technical Document (CTD)
D. Protocol
13. The "investigational product" in a clinical trial can be:
A. A drug
B. A biologic
C. A device
D. ✔ All of the above
, 14. The FDA's 21 CFR Part 11 primarily addresses:
A. Financial disclosure by investigators.
B. ✔ Electronic records and electronic signatures.
C. Informed consent requirements.
D. IND safety reporting.
15. An amendment to an Investigational New Drug (IND) application is required
for:
A. Any change to the protocol.
B. ✔ Any change that significantly affects the safety, scope, or scientific quality of
the investigation.
C. Any change to the Investigator's Brochure.
D. All protocol deviations.
16. The purpose of a Clinical Trial Application (CTA) in the EU is analogous to
what in the US?
A. The Institutional Review Board (IRB) submission
B. ✔ The Investigational New Drug (IND) application
C. The New Drug Application (NDA)
D. The Investigator's Brochure (IB)
17. According to ICH-GCP, who is responsible for the accuracy and validity of the
data reported in the Case Report Form (CRF)?
A. The Sponsor (CRA)
B. The Data Management Team
C. ✔ The Investigator
D. The IRB/IEC
18. What is the primary purpose of a pre-study site selection visit?
A. To train the site staff.
B. To review source documents for enrolled participants.
C. ✔ To assess the site's capability and resources to conduct the trial.
D. To close out the study.
