Regulatory perspectives of clinical trials: ICH-GCP overview MCQs With Answer

Introduction:

Regulatory perspectives of clinical trials: ICH-GCP overview MCQs With Answer is a focused question bank designed for M.Pharm students preparing for advanced coursework and exams in Clinical Research and Pharmacovigilance. This set emphasizes ICH-GCP principles, investigator and sponsor responsibilities, essential documentation, safety reporting, monitoring strategies, and modern regulatory expectations such as risk-based monitoring and electronic records. Each MCQ probes conceptual understanding and practical application in regulated clinical trials, helping learners internalize compliance requirements, prepare for inspections, and implement quality systems that protect participant safety and ensure credible data. Answers are provided to reinforce learning and self-assessment.

Q1. What is the primary objective of ICH-GCP?

• To shorten drug development timelines through flexible trial designs
• To protect the rights, safety, and well-being of trial subjects and ensure credible clinical data
• To mandate specific statistical methods for all clinical trials
• To standardize drug labelling across regions

Correct Answer: To protect the rights, safety, and well-being of trial subjects and ensure credible clinical data

Q2. Which ICH guideline contains the international Good Clinical Practice standard commonly cited as the core GCP document?

• ICH E2A
• ICH Q9
• ICH E6(R2)
• ICH M4

Correct Answer: ICH E6(R2)

Q3. Which of the following is a principal regulatory responsibility of the sponsor under ICH-GCP?

• Obtaining informed consent from every participant
• Selecting qualified investigators and ensuring adequate monitoring of the trial
• Preparing hospital medical records for source documentation
• Reviewing daily nursing notes at investigator sites

Correct Answer: Selecting qualified investigators and ensuring adequate monitoring of the trial

Q4. Under ICH-GCP, a key responsibility of the investigator is to:

• Ensure the investigational product is marketed at the study site
• Ensure the rights, safety, and welfare of trial subjects and obtain informed consent
• Perform all laboratory assays personally
• Provide regulatory approval to the sponsor

Correct Answer: Ensure the rights, safety, and welfare of trial subjects and obtain informed consent

Q5. Which of the following items is NOT considered an essential document per ICH-GCP?

• Case Report Forms (CRFs)
• Signed informed consent forms
• Study protocol and amendments
• Company annual report to shareholders

Correct Answer: Company annual report to shareholders

Q6. Which element is NOT explicitly required to be included in the informed consent form according to ICH-GCP?

• A description of foreseeable risks and discomforts
• Alternative treatments or procedures that may be advantageous
• Assurance of treatment for any unrelated future illnesses
• A statement that participation is voluntary and can be withdrawn

Correct Answer: Assurance of treatment for any unrelated future illnesses

Q7. For a suspected unexpected serious adverse reaction (SUSAR) that is life-threatening, within how many days must the sponsor report to regulatory authorities according to ICH expectations?

• 1 day
• 7 days
• 30 days
• 90 days

Correct Answer: 7 days

Q8. ICH E6(R2) introduced enhanced expectations emphasizing which of the following regulatory quality approaches?

• 100% source data verification for every subject
• Risk-based quality management and centralized monitoring
• Replacement of sponsors by contract research organizations
• Mandatory single global ethics committee review

Correct Answer: Risk-based quality management and centralized monitoring

Q9. Which of the following best defines “source data” in the context of ICH-GCP?

• Data transcribed into the sponsor’s clinical database only
• Original records and certified copies that are the first recording of clinical findings
• Only lab values reported in the final study report
• Investigator promotional materials for the trial

Correct Answer: Original records and certified copies that are the first recording of clinical findings

Q10. Which activity is NOT considered a monitoring function performed by the sponsor or its representative under ICH-GCP?

• Verifying that the trial is conducted according to the protocol
• Ensuring the investigational product is stored correctly
• Conducting a regulatory inspection on behalf of a national authority
• Checking that informed consent was obtained appropriately

Correct Answer: Conducting a regulatory inspection on behalf of a national authority

Q11. What is the primary role of an Ethics Committee/Institutional Review Board (IRB) in the regulatory framework of clinical trials?

• To manufacture the investigational product
• To independently review and approve trial protocol, informed consent and ongoing safety
• To oversee sponsor financial audits
• To recruit trial subjects directly for the sponsor

Correct Answer: To independently review and approve trial protocol, informed consent and ongoing safety

Q12. The Investigator’s Brochure (IB) is intended to provide:

• Marketing claims about the product for patients
• A summary of clinical and nonclinical data relevant to the investigational product’s safety and efficacy
• Regulatory approval status in each country
• Daily instructions for clinical site administrative staff

Correct Answer: A summary of clinical and nonclinical data relevant to the investigational product’s safety and efficacy

Q13. Per ICH-GCP, essential documents should generally be retained for a minimum period of:

• 6 months after study completion
• 2 years after the last marketing approval in an ICH region or longer if required by applicable regulations
• Indefinitely without any specification
• Until the next study at the same site begins

Correct Answer: 2 years after the last marketing approval in an ICH region or longer if required by applicable regulations

Q14. How is a “serious breach” of GCP commonly defined in regulatory terms?

• A minor documentation typo in the trial master file
• A deviation likely to significantly affect the safety or rights of subjects or the reliability of trial data
• A delayed shipment of office supplies to the site
• An investigator changing a visit date with sponsor permission

Correct Answer: A deviation likely to significantly affect the safety or rights of subjects or the reliability of trial data

Q15. Which regulation is most often referenced for U.S. requirements on electronic records and electronic signatures that are relevant to clinical trials?

• ICH E2C
• 21 CFR Part 11
• EU Directive 2001/20/EC
• ICH Q10

Correct Answer: 21 CFR Part 11

Q16. Risk-based monitoring (RBM) primarily focuses monitoring resources on:

• Administrative paperwork only
• Critical data and processes that affect subject safety and data integrity
• Ensuring all site staff have identical job titles
• Maximizing the number of on-site visits regardless of risk

Correct Answer: Critical data and processes that affect subject safety and data integrity

Q17. Who is primarily responsible at the site level for retaining and archiving the investigator site records after trial completion?

• The national regulatory authority
• The sponsor exclusively
• The investigator (or institution) at the site
• The contract research organization’s central office

Correct Answer: The investigator (or institution) at the site

Q18. What is the main regulatory purpose of a delegation log (staff signature and delegation list) in a clinical trial?

• To list patient contact details for recruitment
• To document which trial tasks have been delegated and who is qualified to perform them
• To record the daily drug dispensing quantities for billing
• To provide a public directory of all staff for regulatory websites

Correct Answer: To document which trial tasks have been delegated and who is qualified to perform them

Q19. The ICH E6(R2) revision particularly strengthened guidance on which trial quality concept?

• Mandating single-source data for all endpoints
• Implementing risk-based quality management and proactive quality planning
• Eliminating the need for monitoring plans
• Requiring all trials to be blinded

Correct Answer: Implementing risk-based quality management and proactive quality planning

Q20. During a regulatory inspection, which category of finding is generally considered the most serious and indicates a major threat to subject safety or data integrity?

• Minor observation
• Recommendation for improvement
• Critical finding
• Editorial comment

Correct Answer: Critical finding

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