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) Ensure that clinical trials are conducted ethically and that data are credible
B) Reduce the cost of drug development
C) Eliminate the need for informed consent
D) Speed up the approval process for new drugs
Answer: A
Explanation: ICH GCP (International Council for Harmonisation – Good Clinical Practice) 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
Explanation: ICH GCP does not mandate placebo controls; the choice of comparator depends on the
scientific question and ethical considerations.
3. True or False: The FDA’s regulations for clinical trials are codified in Title 21 of the Code of Federal
Regulations (CFR).
Answer: True
,Explanation: FDA regulations for drugs (21 CFR 312), biologics, and devices (21 CFR 812), as well as IRBs
(21 CFR 56) and informed consent (21 CFR 50), are found in Title 21.
4. The Belmont Report established three fundamental ethical principles for research involving human
subjects. They are:
A) Respect for persons, beneficence, justice
B) Autonomy, nonmaleficence, beneficence
C) Confidentiality, privacy, informed consent
D) Randomization, blinding, control
Answer: A
Explanation: The Belmont Report (1979) identifies: Respect for persons (autonomy), Beneficence
(maximize benefits, minimize harms), and Justice (fair distribution of burdens and benefits).
5. True or False: The Declaration of Helsinki was first adopted by the World Medical Association in 1964
and has been revised multiple times.
Answer: True
Explanation: The Declaration of Helsinki is a foundational ethical document for human subject research,
emphasizing the rights of subjects over scientific interests.
6. Under ICH GCP, the responsibility for the initiation and management of a clinical trial belongs to the:
A) Clinical research coordinator (CRC)
B) Sponsor
C) Investigator
D) Contract research organization (CRO)
Answer: C
Explanation: The Investigator is responsible for the conduct of the trial at the site, including protection
of subjects, adherence to protocol, and data integrity.
7. Which of the following is a required component of informed consent according to 21 CFR 50.25?
,A) A statement that the study involves research
B) A description of any reasonably foreseeable risks or discomforts
C) A statement that participation is voluntary
D) All of the above
Answer: D
Explanation: The eight basic elements of informed consent include: research statement, purpose,
duration, risks, benefits, alternatives, confidentiality, voluntary participation, and contact information.
8. True or False: A subject may withdraw from a clinical trial at any time without penalty.
Answer: True
Explanation: Informed consent requires that subjects be informed of their right to withdraw at any time
without affecting their medical care.
9. According to ICH GCP, the Investigator’s Brochure (IB) must be reviewed and updated at least:
A) Every 6 months
B) Annually
C) Every 2 years
D) When significant new information becomes available
Answer: B
Explanation: ICH GCP E6(R2) requires that the IB be reviewed at least annually and updated as needed.
10. True or False: The IRB has the authority to approve, require modifications, or disapprove research.
Answer: True
Explanation: IRBs review research protocols, informed consent forms, and other materials to ensure
protection of human subjects.
11. Under FDA regulations, an “unanticipated problem involving risks to subjects or others” (UPIRSO)
must be reported to the IRB within:
, A) 5 working days
B) 15 days
C) 30 days
D) 1 year
Answer: A
Explanation: OHRP guidance states that unanticipated problems that are serious and unexpected should
be reported promptly, typically within 5 working days.
12. Which of the following is not a required element of the protocol according to ICH GCP?
A) Statistical methods to be used
B) The investigator’s curriculum vitae
C) Inclusion and exclusion criteria
D) Description of adverse event reporting procedures
Answer: B
Explanation: The investigator’s CV is not part of the protocol; it is kept in the investigator’s site file.
13. True or False: The sponsor may delegate any of its responsibilities to a CRO.
Answer: True
Explanation: Sponsors may transfer responsibilities to a CRO, but the sponsor retains ultimate
responsibility for the quality and integrity of the trial.
14. The “Certificate of Confidentiality” issued by NIH or other agencies:
A) Prevents disclosure of research data in legal proceedings
B) Waives the need for informed consent
C) Allows the sponsor to keep results secret
D) Is required for all clinical trials
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) Ensure that clinical trials are conducted ethically and that data are credible
B) Reduce the cost of drug development
C) Eliminate the need for informed consent
D) Speed up the approval process for new drugs
Answer: A
Explanation: ICH GCP (International Council for Harmonisation – Good Clinical Practice) 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
Explanation: ICH GCP does not mandate placebo controls; the choice of comparator depends on the
scientific question and ethical considerations.
3. True or False: The FDA’s regulations for clinical trials are codified in Title 21 of the Code of Federal
Regulations (CFR).
Answer: True
,Explanation: FDA regulations for drugs (21 CFR 312), biologics, and devices (21 CFR 812), as well as IRBs
(21 CFR 56) and informed consent (21 CFR 50), are found in Title 21.
4. The Belmont Report established three fundamental ethical principles for research involving human
subjects. They are:
A) Respect for persons, beneficence, justice
B) Autonomy, nonmaleficence, beneficence
C) Confidentiality, privacy, informed consent
D) Randomization, blinding, control
Answer: A
Explanation: The Belmont Report (1979) identifies: Respect for persons (autonomy), Beneficence
(maximize benefits, minimize harms), and Justice (fair distribution of burdens and benefits).
5. True or False: The Declaration of Helsinki was first adopted by the World Medical Association in 1964
and has been revised multiple times.
Answer: True
Explanation: The Declaration of Helsinki is a foundational ethical document for human subject research,
emphasizing the rights of subjects over scientific interests.
6. Under ICH GCP, the responsibility for the initiation and management of a clinical trial belongs to the:
A) Clinical research coordinator (CRC)
B) Sponsor
C) Investigator
D) Contract research organization (CRO)
Answer: C
Explanation: The Investigator is responsible for the conduct of the trial at the site, including protection
of subjects, adherence to protocol, and data integrity.
7. Which of the following is a required component of informed consent according to 21 CFR 50.25?
,A) A statement that the study involves research
B) A description of any reasonably foreseeable risks or discomforts
C) A statement that participation is voluntary
D) All of the above
Answer: D
Explanation: The eight basic elements of informed consent include: research statement, purpose,
duration, risks, benefits, alternatives, confidentiality, voluntary participation, and contact information.
8. True or False: A subject may withdraw from a clinical trial at any time without penalty.
Answer: True
Explanation: Informed consent requires that subjects be informed of their right to withdraw at any time
without affecting their medical care.
9. According to ICH GCP, the Investigator’s Brochure (IB) must be reviewed and updated at least:
A) Every 6 months
B) Annually
C) Every 2 years
D) When significant new information becomes available
Answer: B
Explanation: ICH GCP E6(R2) requires that the IB be reviewed at least annually and updated as needed.
10. True or False: The IRB has the authority to approve, require modifications, or disapprove research.
Answer: True
Explanation: IRBs review research protocols, informed consent forms, and other materials to ensure
protection of human subjects.
11. Under FDA regulations, an “unanticipated problem involving risks to subjects or others” (UPIRSO)
must be reported to the IRB within:
, A) 5 working days
B) 15 days
C) 30 days
D) 1 year
Answer: A
Explanation: OHRP guidance states that unanticipated problems that are serious and unexpected should
be reported promptly, typically within 5 working days.
12. Which of the following is not a required element of the protocol according to ICH GCP?
A) Statistical methods to be used
B) The investigator’s curriculum vitae
C) Inclusion and exclusion criteria
D) Description of adverse event reporting procedures
Answer: B
Explanation: The investigator’s CV is not part of the protocol; it is kept in the investigator’s site file.
13. True or False: The sponsor may delegate any of its responsibilities to a CRO.
Answer: True
Explanation: Sponsors may transfer responsibilities to a CRO, but the sponsor retains ultimate
responsibility for the quality and integrity of the trial.
14. The “Certificate of Confidentiality” issued by NIH or other agencies:
A) Prevents disclosure of research data in legal proceedings
B) Waives the need for informed consent
C) Allows the sponsor to keep results secret
D) Is required for all clinical trials
