ACRP CCRC EXAM PREP 2026 QUESTIONS AND CORRECT
ANSWERS (ORIGINAL PRACTICE ANSWERS) PLUS
RATIONALES 2026 Q&A | INSTANT DOWNLOAD PDF.
CORE DOMAINS
Scientific Concepts and Research Design
Ethical and Participant Safety Considerations
Product Development and Regulation
Clinical Trial Operations (GCPs)
Study and Site Management
Data Management and Informatics
INTRODUCTION
This assessment evaluates the knowledge and clinical
judgment required of Certified Clinical Research Coordinators.
It measures understanding of scientific concepts, research
design, ethical principles, participant safety, product
development, regulatory compliance, Good Clinical Practice
under ICH E6(R3), study site management, and data
management. The examination uses multiple-choice and
scenario-based questions that emphasize real-world
application, prioritization of participant welfare, and critical
decision-making. Candidates must demonstrate the ability to
interpret study requirements accurately and make decisions
aligned with ICH GCP and accepted research standards. The
,structure supports comprehensive review and readiness for
the ACRP CCRC certification examination.
SECTION ONE: QUESTIONS 1–69
Question 1
Which document serves as the primary global ethical and
scientific quality standard for designing, conducting,
recording, and reporting clinical trials?
A. Declaration of Helsinki
🟢 B. ICH E6 Good Clinical Practice
C. 21 CFR Part 50
D. Belmont Report
🔴 RATIONALE: ICH E6 GCP is the international ethical and
scientific quality standard for clinical trials involving human
subjects. As of July 2026, ACRP examinations reference ICH
E6(R3), which replaced E6(R2) as the active GCP standard.
Question 2
Which phase of clinical trials primarily assesses safety and
dosage in a small number of healthy volunteers?
A. Phase I
B. Phase II
C. Phase III
D. Phase IV
,🔴 RATIONALE: Phase I trials are designed to determine the
metabolic and pharmacologic actions of the drug in
humans, the side effects associated with increasing doses,
and early evidence of effectiveness.
Question 3
What is the primary purpose of a Phase III clinical trial?
🟢 A. To gather additional information about effectiveness
and safety to evaluate the overall benefit-risk relationship
B. To determine the maximum tolerated dose
C. To assess pharmacokinetics in healthy volunteers
D. To conduct post-marketing surveillance
🔴 RATIONALE: Phase III trials are expanded controlled and
uncontrolled trials performed after preliminary evidence
suggesting effectiveness has been obtained, intended to
gather additional information for evaluating the overall
benefit-risk relationship.
Question 4
Which entity is responsible for reviewing and approving
research involving human subjects to ensure protection of
rights and welfare?
A. The sponsor
B. The FDA
, C. The Institutional Review Board (IRB)
D. The principal investigator
🔴 RATIONALE: The IRB is an appropriately constituted
group formally designated to review and monitor
biomedical research involving human subjects, with
authority to approve, require modifications, or disapprove
research activities.
Question 5
Under ICH E6(R3), which approach is emphasized for quality
management in clinical trials?
🟢 A. Risk-based and proportionate quality management
B. Maximum data collection at all costs
C. Rigid adherence to traditional site-based monitoring
D. Elimination of all protocol deviations
🔴 RATIONALE: ICH E6(R3) advances quality by design and
risk-based quality management in trial conduct and
oversight, promoting proportionality and critical thinking
throughout the clinical trial lifecycle.
Question 6
What is the minimum number of members required for an
IRB according to 21 CFR 56?
ANSWERS (ORIGINAL PRACTICE ANSWERS) PLUS
RATIONALES 2026 Q&A | INSTANT DOWNLOAD PDF.
CORE DOMAINS
Scientific Concepts and Research Design
Ethical and Participant Safety Considerations
Product Development and Regulation
Clinical Trial Operations (GCPs)
Study and Site Management
Data Management and Informatics
INTRODUCTION
This assessment evaluates the knowledge and clinical
judgment required of Certified Clinical Research Coordinators.
It measures understanding of scientific concepts, research
design, ethical principles, participant safety, product
development, regulatory compliance, Good Clinical Practice
under ICH E6(R3), study site management, and data
management. The examination uses multiple-choice and
scenario-based questions that emphasize real-world
application, prioritization of participant welfare, and critical
decision-making. Candidates must demonstrate the ability to
interpret study requirements accurately and make decisions
aligned with ICH GCP and accepted research standards. The
,structure supports comprehensive review and readiness for
the ACRP CCRC certification examination.
SECTION ONE: QUESTIONS 1–69
Question 1
Which document serves as the primary global ethical and
scientific quality standard for designing, conducting,
recording, and reporting clinical trials?
A. Declaration of Helsinki
🟢 B. ICH E6 Good Clinical Practice
C. 21 CFR Part 50
D. Belmont Report
🔴 RATIONALE: ICH E6 GCP is the international ethical and
scientific quality standard for clinical trials involving human
subjects. As of July 2026, ACRP examinations reference ICH
E6(R3), which replaced E6(R2) as the active GCP standard.
Question 2
Which phase of clinical trials primarily assesses safety and
dosage in a small number of healthy volunteers?
A. Phase I
B. Phase II
C. Phase III
D. Phase IV
,🔴 RATIONALE: Phase I trials are designed to determine the
metabolic and pharmacologic actions of the drug in
humans, the side effects associated with increasing doses,
and early evidence of effectiveness.
Question 3
What is the primary purpose of a Phase III clinical trial?
🟢 A. To gather additional information about effectiveness
and safety to evaluate the overall benefit-risk relationship
B. To determine the maximum tolerated dose
C. To assess pharmacokinetics in healthy volunteers
D. To conduct post-marketing surveillance
🔴 RATIONALE: Phase III trials are expanded controlled and
uncontrolled trials performed after preliminary evidence
suggesting effectiveness has been obtained, intended to
gather additional information for evaluating the overall
benefit-risk relationship.
Question 4
Which entity is responsible for reviewing and approving
research involving human subjects to ensure protection of
rights and welfare?
A. The sponsor
B. The FDA
, C. The Institutional Review Board (IRB)
D. The principal investigator
🔴 RATIONALE: The IRB is an appropriately constituted
group formally designated to review and monitor
biomedical research involving human subjects, with
authority to approve, require modifications, or disapprove
research activities.
Question 5
Under ICH E6(R3), which approach is emphasized for quality
management in clinical trials?
🟢 A. Risk-based and proportionate quality management
B. Maximum data collection at all costs
C. Rigid adherence to traditional site-based monitoring
D. Elimination of all protocol deviations
🔴 RATIONALE: ICH E6(R3) advances quality by design and
risk-based quality management in trial conduct and
oversight, promoting proportionality and critical thinking
throughout the clinical trial lifecycle.
Question 6
What is the minimum number of members required for an
IRB according to 21 CFR 56?
