CITI GCP Training Questions and
Answers | Latest Version | 2025/2026 |
Correct & Verified
What is the primary purpose of Good Clinical Practice (GCP)?
✔✔ To ensure the safety, rights, and well-being of clinical trial participants and the integrity of
trial data.
Who is responsible for ensuring compliance with GCP in a clinical trial?
✔✔ The principal investigator, sponsor, and study team collectively.
What must be obtained from every participant before enrolling them in a clinical trial?
✔✔ Informed consent, demonstrating understanding of risks, benefits, and study procedures.
Why is accurate documentation essential in clinical trials?
✔✔ To maintain data integrity, allow audits, and ensure regulatory compliance.
What is the role of the Institutional Review Board (IRB) or Ethics Committee in GCP?
✔✔ To review and approve study protocols to protect participants’ rights and safety.
1
,What is a protocol in clinical research?
✔✔ A detailed plan outlining study objectives, design, procedures, and safety measures.
Why must adverse events be reported promptly during a trial?
✔✔ To ensure participant safety and regulatory compliance.
What is the purpose of source documents in a clinical trial?
✔✔ To provide original evidence of participant data and study conduct.
What is the difference between an adverse event and a serious adverse event?
✔✔ An adverse event is any unfavorable occurrence; a serious adverse event results in death,
hospitalization, or significant disability.
Why is participant confidentiality important in clinical trials?
✔✔ To protect privacy and comply with ethical and legal standards.
What is the role of the sponsor in a clinical trial?
2
,✔✔ To provide funding, oversight, and ensure regulatory compliance.
Why must investigators follow the approved protocol without deviation?
✔✔ To maintain participant safety and data validity.
What is the purpose of monitoring in clinical trials?
✔✔ To verify compliance with the protocol, GCP, and regulatory requirements.
Why must clinical trial data be attributable, legible, contemporaneous, original, and accurate
(ALCOA)?
✔✔ To ensure integrity, reliability, and audit readiness.
What is the importance of training study staff in GCP?
✔✔ To ensure proper conduct, participant safety, and data quality.
Why must a clinical trial have clear inclusion and exclusion criteria?
✔✔ To protect participants and maintain study validity.
3
, What is an investigational product in clinical research?
✔✔ A drug, device, or intervention being studied that is not yet approved for general use.
Why should deviations from the protocol be documented and reported?
✔✔ To maintain transparency, regulatory compliance, and participant safety.
What is the purpose of informed consent documentation?
✔✔ To provide proof that participants voluntarily agreed to participate after understanding the
study.
What is the primary responsibility of the principal investigator?
✔✔ To oversee the study, ensure participant safety, and comply with GCP and protocol.
Why is it important to store clinical trial data securely?
✔✔ To protect confidentiality and prevent unauthorized access or tampering.
What should be done if a participant decides to withdraw from a trial?
4
Answers | Latest Version | 2025/2026 |
Correct & Verified
What is the primary purpose of Good Clinical Practice (GCP)?
✔✔ To ensure the safety, rights, and well-being of clinical trial participants and the integrity of
trial data.
Who is responsible for ensuring compliance with GCP in a clinical trial?
✔✔ The principal investigator, sponsor, and study team collectively.
What must be obtained from every participant before enrolling them in a clinical trial?
✔✔ Informed consent, demonstrating understanding of risks, benefits, and study procedures.
Why is accurate documentation essential in clinical trials?
✔✔ To maintain data integrity, allow audits, and ensure regulatory compliance.
What is the role of the Institutional Review Board (IRB) or Ethics Committee in GCP?
✔✔ To review and approve study protocols to protect participants’ rights and safety.
1
,What is a protocol in clinical research?
✔✔ A detailed plan outlining study objectives, design, procedures, and safety measures.
Why must adverse events be reported promptly during a trial?
✔✔ To ensure participant safety and regulatory compliance.
What is the purpose of source documents in a clinical trial?
✔✔ To provide original evidence of participant data and study conduct.
What is the difference between an adverse event and a serious adverse event?
✔✔ An adverse event is any unfavorable occurrence; a serious adverse event results in death,
hospitalization, or significant disability.
Why is participant confidentiality important in clinical trials?
✔✔ To protect privacy and comply with ethical and legal standards.
What is the role of the sponsor in a clinical trial?
2
,✔✔ To provide funding, oversight, and ensure regulatory compliance.
Why must investigators follow the approved protocol without deviation?
✔✔ To maintain participant safety and data validity.
What is the purpose of monitoring in clinical trials?
✔✔ To verify compliance with the protocol, GCP, and regulatory requirements.
Why must clinical trial data be attributable, legible, contemporaneous, original, and accurate
(ALCOA)?
✔✔ To ensure integrity, reliability, and audit readiness.
What is the importance of training study staff in GCP?
✔✔ To ensure proper conduct, participant safety, and data quality.
Why must a clinical trial have clear inclusion and exclusion criteria?
✔✔ To protect participants and maintain study validity.
3
, What is an investigational product in clinical research?
✔✔ A drug, device, or intervention being studied that is not yet approved for general use.
Why should deviations from the protocol be documented and reported?
✔✔ To maintain transparency, regulatory compliance, and participant safety.
What is the purpose of informed consent documentation?
✔✔ To provide proof that participants voluntarily agreed to participate after understanding the
study.
What is the primary responsibility of the principal investigator?
✔✔ To oversee the study, ensure participant safety, and comply with GCP and protocol.
Why is it important to store clinical trial data securely?
✔✔ To protect confidentiality and prevent unauthorized access or tampering.
What should be done if a participant decides to withdraw from a trial?
4
