[GCP] Good Clinical Practice GCP
Certification Review Guide
**Question 1. Which ICH GCP principle states that the rights, safety, and well‑being of trial
subjects take precedence over the interests of science and society?**
A) Scientific integrity
B) Ethics and safety
C) Quality systems
D) Risk‑based monitoring
Answer: B
Explanation: The Ethics and Safety principle explicitly requires that the rights, safety, and
well‑being of subjects are the primary consideration in any clinical trial.
**Question 2. The Declaration of Helsinki is primarily a set of guidelines for which of the
following?**
A) Data management standards
B) Clinical trial monitoring procedures
C) Ethical conduct of medical research involving human subjects
D) Statistical analysis plans
Answer: C
Explanation: The Declaration of Helsinki provides ethical principles for medical research
involving human subjects, forming a cornerstone of GCP ethical requirements.
**Question 3. Under ICH GCP, a scientifically sound protocol must include which of the
following elements?**
A) Detailed marketing strategy for the investigational product
B) Rationale for the study, objectives, design, and statistical considerations
C) List of all global regulatory agencies
D) Investigator’s personal opinions on the drug
, [GCP] Good Clinical Practice GCP
Certification Review Guide
Answer: B
Explanation: A scientifically sound protocol must contain a clear rationale, objectives, design,
methodology, and statistical plan to ensure scientific validity.
**Question 4. Which document demonstrates that a sponsor has implemented a quality system
to assure trial conduct?**
A) Investigator’s brochure (IB)
B) Quality Management Plan (QMP)
C) Informed consent form (ICF)
D) Case report form (CRF)
Answer: B
Explanation: The Quality Management Plan outlines the sponsor’s quality system, procedures,
and controls to ensure high‑quality trial conduct.
**Question 5. According to ICH GCP, what is the minimum composition of an Institutional
Review Board (IRB) or Independent Ethics Committee (IEC)?**
A) At least three members, including a layperson and a scientist
B) Only physicians with clinical trial experience
C) Only legal experts
D) Minimum of ten members, all from the same institution
Answer: A
Explanation: An IRB/IEC must have at least three members, with a diversity of expertise,
including a non‑scientist layperson to represent community interests.
**Question 6. Which of the following is NOT a primary responsibility of an IRB/IEC during the
initial review?**
A) Assessing risk/benefit ratio of the study
, [GCP] Good Clinical Practice GCP
Certification Review Guide
B) Verifying investigator’s salary
C) Ensuring informed consent documents are understandable
D) Confirming that the protocol complies with applicable regulations
Answer: B
Explanation: Investigator compensation is not an IRB/IEC function; the board focuses on ethical
and regulatory compliance, not personnel remuneration.
**Question 7. When must an IRB/IEC provide continuing review of an ongoing clinical trial?**
A) Only when a serious adverse event occurs
B) At least annually, or more frequently if required by the protocol or regulations
C) Never, after initial approval
D) Only when the sponsor requests it
Answer: B
Explanation: Continuing review must occur at least once a year, or more often if the protocol or
regulatory authorities dictate.
**Question 8. Which action can an IRB/IEC take if a study is found to be non‑compliant with
ethical standards?**
A) Issue a warning and allow the study to continue unchanged
B) Approve the study with modifications, suspend, or terminate it
C) Transfer the study to another institution without review
D) Ignore the non‑compliance if the sponsor is a large pharmaceutical company
Answer: B
Explanation: The IRB/IEC can require modifications, suspend, or disapprove/terminate a study
to protect participants and ensure ethical conduct.
, [GCP] Good Clinical Practice GCP
Certification Review Guide
**Question 9. What is the required retention period for essential GCP documents after the
study is completed?**
A) 2 years
B) 5 years after the last marketing approval of the investigational product, or at least 2 years
after study completion if no approval
C) Until the sponsor decides to discard them
D) 10 years from the first patient enrollment
Answer: B
Explanation: GCP requires documents to be retained for at least 2 years after study completion,
or 5 years after the last marketing approval, whichever is longer.
**Question 10. Which of the following best describes the investigator’s primary qualification
requirement for conducting a clinical trial?**
A) Must have a PhD in any scientific discipline
B) Must possess appropriate medical or scientific training and experience related to the trial
C) Must be a member of the sponsor’s senior management team
D) Must have published at least ten articles on the investigational product
Answer: B
Explanation: Investigators must have the appropriate education, training, and experience to
conduct the specific trial safely and ethically.
**Question 11. An investigator must maintain an up‑to‑date curriculum vitae (CV) for which
purpose?**
A) To demonstrate eligibility for future grant applications only
B) To satisfy sponsor and IRB/IEC requirements for qualification verification
C) To provide a public record for patients to review
D) To calculate the investigator’s salary
Certification Review Guide
**Question 1. Which ICH GCP principle states that the rights, safety, and well‑being of trial
subjects take precedence over the interests of science and society?**
A) Scientific integrity
B) Ethics and safety
C) Quality systems
D) Risk‑based monitoring
Answer: B
Explanation: The Ethics and Safety principle explicitly requires that the rights, safety, and
well‑being of subjects are the primary consideration in any clinical trial.
**Question 2. The Declaration of Helsinki is primarily a set of guidelines for which of the
following?**
A) Data management standards
B) Clinical trial monitoring procedures
C) Ethical conduct of medical research involving human subjects
D) Statistical analysis plans
Answer: C
Explanation: The Declaration of Helsinki provides ethical principles for medical research
involving human subjects, forming a cornerstone of GCP ethical requirements.
**Question 3. Under ICH GCP, a scientifically sound protocol must include which of the
following elements?**
A) Detailed marketing strategy for the investigational product
B) Rationale for the study, objectives, design, and statistical considerations
C) List of all global regulatory agencies
D) Investigator’s personal opinions on the drug
, [GCP] Good Clinical Practice GCP
Certification Review Guide
Answer: B
Explanation: A scientifically sound protocol must contain a clear rationale, objectives, design,
methodology, and statistical plan to ensure scientific validity.
**Question 4. Which document demonstrates that a sponsor has implemented a quality system
to assure trial conduct?**
A) Investigator’s brochure (IB)
B) Quality Management Plan (QMP)
C) Informed consent form (ICF)
D) Case report form (CRF)
Answer: B
Explanation: The Quality Management Plan outlines the sponsor’s quality system, procedures,
and controls to ensure high‑quality trial conduct.
**Question 5. According to ICH GCP, what is the minimum composition of an Institutional
Review Board (IRB) or Independent Ethics Committee (IEC)?**
A) At least three members, including a layperson and a scientist
B) Only physicians with clinical trial experience
C) Only legal experts
D) Minimum of ten members, all from the same institution
Answer: A
Explanation: An IRB/IEC must have at least three members, with a diversity of expertise,
including a non‑scientist layperson to represent community interests.
**Question 6. Which of the following is NOT a primary responsibility of an IRB/IEC during the
initial review?**
A) Assessing risk/benefit ratio of the study
, [GCP] Good Clinical Practice GCP
Certification Review Guide
B) Verifying investigator’s salary
C) Ensuring informed consent documents are understandable
D) Confirming that the protocol complies with applicable regulations
Answer: B
Explanation: Investigator compensation is not an IRB/IEC function; the board focuses on ethical
and regulatory compliance, not personnel remuneration.
**Question 7. When must an IRB/IEC provide continuing review of an ongoing clinical trial?**
A) Only when a serious adverse event occurs
B) At least annually, or more frequently if required by the protocol or regulations
C) Never, after initial approval
D) Only when the sponsor requests it
Answer: B
Explanation: Continuing review must occur at least once a year, or more often if the protocol or
regulatory authorities dictate.
**Question 8. Which action can an IRB/IEC take if a study is found to be non‑compliant with
ethical standards?**
A) Issue a warning and allow the study to continue unchanged
B) Approve the study with modifications, suspend, or terminate it
C) Transfer the study to another institution without review
D) Ignore the non‑compliance if the sponsor is a large pharmaceutical company
Answer: B
Explanation: The IRB/IEC can require modifications, suspend, or disapprove/terminate a study
to protect participants and ensure ethical conduct.
, [GCP] Good Clinical Practice GCP
Certification Review Guide
**Question 9. What is the required retention period for essential GCP documents after the
study is completed?**
A) 2 years
B) 5 years after the last marketing approval of the investigational product, or at least 2 years
after study completion if no approval
C) Until the sponsor decides to discard them
D) 10 years from the first patient enrollment
Answer: B
Explanation: GCP requires documents to be retained for at least 2 years after study completion,
or 5 years after the last marketing approval, whichever is longer.
**Question 10. Which of the following best describes the investigator’s primary qualification
requirement for conducting a clinical trial?**
A) Must have a PhD in any scientific discipline
B) Must possess appropriate medical or scientific training and experience related to the trial
C) Must be a member of the sponsor’s senior management team
D) Must have published at least ten articles on the investigational product
Answer: B
Explanation: Investigators must have the appropriate education, training, and experience to
conduct the specific trial safely and ethically.
**Question 11. An investigator must maintain an up‑to‑date curriculum vitae (CV) for which
purpose?**
A) To demonstrate eligibility for future grant applications only
B) To satisfy sponsor and IRB/IEC requirements for qualification verification
C) To provide a public record for patients to review
D) To calculate the investigator’s salary
