ACRP CCRC Exam Prep 2026 | 138 Practice Questions with Answers &
Explanations | Clinical Research Certification Guide
Section 1: Good Clinical Practice (GCP) & Regulatory Framework (Questions
1–25)
1. The primary purpose of ICH GCP guidelines is to:
A) Reduce the cost of drug development
B) Eliminate the need for informed consent
C) Ensure that clinical trials are conducted ethically and that data are credible
D) Speed up the approval process for new drugs
Answer C: Ensure that clinical trials are conducted ethically and that data are
credible
Rationale: ICH GCP provides an international standard for the design,
conduct, recording, and reporting of clinical trials to protect human subjects
and ensure data integrity.
,2. Which of the following is NOT a core principle of ICH GCP?
A) Clinical trials should be conducted in accordance with ethical principles
from the Declaration of Helsinki
B) Benefits should outweigh risks
C) All clinical trials must be conducted using a placebo control
D) Informed consent must be obtained from each subject
Answer C: All clinical trials must be conducted using a placebo control
Rationale: ICH GCP does not mandate placebo controls; the choice of
comparator depends on the scientific question and ethical considerations.
3. The ICH E6(R3) guideline became the active reference for ACRP
examinations effective:
A) January 1, 2026
B) July 15, 2026
C) October 1, 2026
D) December 31, 2026
Answer B: July 15, 2026
Rationale: ACRP replaced ICH E6(R2) with ICH E6(R3) across all its certification
examinations beginning July 15, 2026.
,4. According to ICH GCP, the responsibility for the protection of clinical trial
subjects rests with:
A) IRB/IEC only
B) Investigator only
C) Sponsor only
D) All of the above
Answer D: All of the above
Rationale: Protection of subjects is a shared responsibility among the IRB/IEC,
investigator, and sponsor.
5. The Declaration of Helsinki primarily addresses:
A) Drug manufacturing standards
B) Ethical principles for medical research involving human subjects
C) Statistical analysis methods
D) Investigator financial disclosure
Answer B: Ethical principles for medical research involving human subjects
Rationale: The Declaration of Helsinki is a statement of ethical principles for
medical research involving human subjects, including research on identifiable
human material and data.
, 6. Which document outlines the responsibilities of investigators in a clinical
trial?
A) ICH E6(R3) GCP guidelines
B) FDA Form 1572 only
C) Investigator's Brochure
D) Clinical Study Report
Answer A: ICH E6(R3) GCP guidelines
Rationale: ICH E6(R3) provides comprehensive guidance on investigator
responsibilities, including protocol adherence and subject safety.
7. A clinical trial protocol should reflect:
A) Reasonable costs for the clinical trial
B) Minimized sample sizes to reduce risks
C) Sound scientific design
D) The use of control groups whenever possible
Answer C: Sound scientific design
Rationale: Clinical trial protocols should be based on sound scientific design to
ensure valid and reliable results.
8. Which of the following is an essential document required for clinical trial
conduct?
Explanations | Clinical Research Certification Guide
Section 1: Good Clinical Practice (GCP) & Regulatory Framework (Questions
1–25)
1. The primary purpose of ICH GCP guidelines is to:
A) Reduce the cost of drug development
B) Eliminate the need for informed consent
C) Ensure that clinical trials are conducted ethically and that data are credible
D) Speed up the approval process for new drugs
Answer C: Ensure that clinical trials are conducted ethically and that data are
credible
Rationale: ICH GCP provides an international standard for the design,
conduct, recording, and reporting of clinical trials to protect human subjects
and ensure data integrity.
,2. Which of the following is NOT a core principle of ICH GCP?
A) Clinical trials should be conducted in accordance with ethical principles
from the Declaration of Helsinki
B) Benefits should outweigh risks
C) All clinical trials must be conducted using a placebo control
D) Informed consent must be obtained from each subject
Answer C: All clinical trials must be conducted using a placebo control
Rationale: ICH GCP does not mandate placebo controls; the choice of
comparator depends on the scientific question and ethical considerations.
3. The ICH E6(R3) guideline became the active reference for ACRP
examinations effective:
A) January 1, 2026
B) July 15, 2026
C) October 1, 2026
D) December 31, 2026
Answer B: July 15, 2026
Rationale: ACRP replaced ICH E6(R2) with ICH E6(R3) across all its certification
examinations beginning July 15, 2026.
,4. According to ICH GCP, the responsibility for the protection of clinical trial
subjects rests with:
A) IRB/IEC only
B) Investigator only
C) Sponsor only
D) All of the above
Answer D: All of the above
Rationale: Protection of subjects is a shared responsibility among the IRB/IEC,
investigator, and sponsor.
5. The Declaration of Helsinki primarily addresses:
A) Drug manufacturing standards
B) Ethical principles for medical research involving human subjects
C) Statistical analysis methods
D) Investigator financial disclosure
Answer B: Ethical principles for medical research involving human subjects
Rationale: The Declaration of Helsinki is a statement of ethical principles for
medical research involving human subjects, including research on identifiable
human material and data.
, 6. Which document outlines the responsibilities of investigators in a clinical
trial?
A) ICH E6(R3) GCP guidelines
B) FDA Form 1572 only
C) Investigator's Brochure
D) Clinical Study Report
Answer A: ICH E6(R3) GCP guidelines
Rationale: ICH E6(R3) provides comprehensive guidance on investigator
responsibilities, including protocol adherence and subject safety.
7. A clinical trial protocol should reflect:
A) Reasonable costs for the clinical trial
B) Minimized sample sizes to reduce risks
C) Sound scientific design
D) The use of control groups whenever possible
Answer C: Sound scientific design
Rationale: Clinical trial protocols should be based on sound scientific design to
ensure valid and reliable results.
8. Which of the following is an essential document required for clinical trial
conduct?
