Good Clinical Practice (GCP) in pharmacovigilance studies MCQs With Answer

Good Clinical Practice (GCP) in pharmacovigilance studies MCQs With Answer

Good Clinical Practice (GCP) and pharmacovigilance are essential for safe, ethical clinical trials and post-marketing safety monitoring. This concise, student-focused introduction explains GCP principles, roles of sponsor, investigator, and ethics committee, adverse event (AE) and serious adverse event (SAE) reporting, SUSARs, signal detection, causality assessment, MedDRA coding, PSMF, Periodic Benefit-Risk Evaluation Reports (PBRER), and regulatory compliance (ICH-GCP, local authorities). Clear understanding of safety reporting timelines, documentation, informed consent, data integrity (ALCOA), risk management plans, and audit/CAPA processes prepares B. Pharm students for real-world pharmacovigilance responsibilities. These MCQs include answers to reinforce learning and improve practical exam readiness.

Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the best concise definition of Good Clinical Practice (GCP)?

• An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials involving human subjects
• A set of marketing rules for promoting approved drugs
• A manufacturing quality control guideline for pharmaceutical production
• A legal document only used by regulatory inspectors

Correct Answer: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials involving human subjects

Q2. What is the primary objective of pharmacovigilance?

• To develop new drugs faster
• To detect, assess, understand and prevent adverse effects or any other drug-related problems
• To increase sales of marketed drugs
• To design clinical trial protocols

Correct Answer: To detect, assess, understand and prevent adverse effects or any other drug-related problems

Q3. Which of the following best describes a Serious Adverse Event (SAE)?

• An event that causes mild nausea only
• An adverse event that results in death, is life‑threatening, requires hospitalization or causes persistent disability
• Any expected side effect listed in the Investigator Brochure
• An administrative error in documentation

Correct Answer: An adverse event that results in death, is life‑threatening, requires hospitalization or causes persistent disability

Q4. What does SUSAR stand for in clinical trial safety reporting?

• Suspected Unexpected Serious Adverse Reaction
• Standard Unmonitored Safety Adverse Report
• Systematic Unexpected Safety Assessment Result
• Serious Unconfirmed Safety Adverse Record

Correct Answer: Suspected Unexpected Serious Adverse Reaction

Q5. What is the typical regulatory timeline for reporting a fatal or life‑threatening SUSAR to regulatory authorities?

• 7 calendar days for initial report
• 90 days for initial report
• 30 days for initial report
• 48 hours for initial report

Correct Answer: 7 calendar days for initial report

Q6. What is the usual timeframe for reporting non‑fatal, non‑life‑threatening SUSARs?

• 15 calendar days
• 24 hours
• 60 calendar days
• 1 year

Correct Answer: 15 calendar days

Q7. Who holds primary responsibility for drug safety reporting and maintaining the pharmacovigilance system during a clinical trial?

• The sponsor
• The patient
• The trial site janitorial staff
• The medical writer only

Correct Answer: The sponsor

Q8. Which action is a key responsibility of the investigator under GCP related to safety?

• Obtaining informed consent and promptly reporting AEs/SAEs to the sponsor and ethics committee
• Only recruiting healthy volunteers
• Publishing trial results before data verification
• Designing the marketing strategy for the drug

Correct Answer: Obtaining informed consent and promptly reporting AEs/SAEs to the sponsor and ethics committee

Q9. ICH‑GCP guidelines primarily aim to:

• Harmonize international standards for protection of trial subjects and assurance of data quality
• Regulate drug prices globally
• Replace all local laws on clinical research
• Describe manufacturing processes for APIs

Correct Answer: Harmonize international standards for protection of trial subjects and assurance of data quality

Q10. What are “source data” in the context of GCP?

• The original documents and records where data are first recorded (e.g., hospital charts, lab reports)
• Only data entered into the final study report
• Summary tables prepared at the end of the study
• Only electronic database backups

Correct Answer: The original documents and records where data are first recorded (e.g., hospital charts, lab reports)

Q11. Which coding dictionary is widely used for coding adverse events in clinical trials and PV?

• MedDRA
• ICD‑10 only
• WHO‑ART exclusively
• SNOMED only

Correct Answer: MedDRA

Q12. What does PBRER stand for?

• Periodic Benefit‑Risk Evaluation Report
• Primary Biological Risk Evaluation Record
• Pharmacovigilance Batch Review and Evaluation Report
• Preclinical Benefit Review and Export Report

Correct Answer: Periodic Benefit‑Risk Evaluation Report

Q13. Which report is specifically used to summarize safety information for an investigational drug during clinical development annually?

• Development Safety Update Report (DSUR)
• Periodic Safety Update Report (PSUR) only
• Annual Marketing Report
• Final Study Report

Correct Answer: Development Safety Update Report (DSUR)

Q14. In MedDRA hierarchy, which level is commonly used for regulatory AE summary statistics?

• Preferred Term (PT)
• Lowest Level Term (LLT) only
• System Organ Class (SOC) only
• High Level Term (HLT) only

Correct Answer: Preferred Term (PT)

Q15. Which statistical method is commonly used in signal detection from spontaneous reporting databases?

• Disproportionality analysis (e.g., PRR, ROR)
• Kaplan‑Meier survival analysis
• ANOVA for continuous outcomes
• Fisher’s exact test for clinical trial randomization

Correct Answer: Disproportionality analysis (e.g., PRR, ROR)

Q16. Which causality assessment method is widely recommended for standardized case assessment in PV?

• WHO‑UMC causality assessment
• Random guessing method
• Marketing department assessment
• Quality control inspection checklist

Correct Answer: WHO‑UMC causality assessment

Q17. According to GCP, informed consent must be obtained:

• Before any trial‑related procedure is performed
• Only after the study is completed
• Only from the sponsor
• When the final study report is published

Correct Answer: Before any trial‑related procedure is performed

Q18. Which acronym summarizes key data integrity principles in clinical research?

• ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate)
• GXP (Good X Production)
• SOP (Safety Oriented Process)
• PBR (Periodic Biological Review)

Correct Answer: ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate)

Q19. Who is primarily responsible for maintaining the Trial Master File (TMF)?

• The sponsor
• The study patient
• The courier company
• The institutional cleaning staff

Correct Answer: The sponsor

Q20. Which document describes the pharmacovigilance system of a marketing authorization holder?

• Pharmacovigilance System Master File (PSMF)
• Investigator Brochure (IB)
• Clinical study protocol only
• Patient informed consent form

Correct Answer: Pharmacovigilance System Master File (PSMF)

Q21. Which independent group monitors participant safety and trial data during large clinical trials?

• Data Safety Monitoring Board (DSMB)
• Ethics Committee janitorial staff
• Marketing steering committee
• Sponsor finance audit team

Correct Answer: Data Safety Monitoring Board (DSMB)

Q22. Essential elements that must be included in informed consent include:

• Purpose of study, procedures, risks, benefits, alternatives, confidentiality and voluntariness
• Only the study title and sponsor name
• Only the expected profit for the sponsor
• Only a summary of preclinical animal studies

Correct Answer: Purpose of study, procedures, risks, benefits, alternatives, confidentiality and voluntariness

Q23. Expedited reporting in clinical trials is primarily the obligation of which party?

• The sponsor
• The trial subject
• The pharmacy distributor
• The local media

Correct Answer: The sponsor

Q24. Which global database is maintained by the Uppsala Monitoring Centre for individual case safety reports (ICSRs)?

• VigiBase
• PubMed
• ClinicalTrials.gov only
• EudraCT

Correct Answer: VigiBase

Q25. What is the difference between an adverse event (AE) and an adverse reaction (AR)?

• An AE is any untoward medical occurrence; an AR is an AE with at least a reasonable causal relationship to the drug
• They are always identical terms with no distinction
• AE refers to marketing complaints; AR refers to manufacturing defects
• AE is only for animals; AR is only for humans

Correct Answer: An AE is any untoward medical occurrence; an AR is an AE with at least a reasonable causal relationship to the drug

Q26. One fundamental GCP principle is that:

• The rights, safety and well‑being of trial subjects take precedence over the interests of science and society
• Sponsors may override subject safety to meet timelines
• Trial data need not be verifiable from source documents
• Informed consent can be verbal only for high‑risk studies

Correct Answer: The rights, safety and well‑being of trial subjects take precedence over the interests of science and society

Q27. The Investigator Brochure (IB) should contain:

• Relevant preclinical and clinical safety and efficacy information about the investigational product
• Only the sponsor’s marketing plan
• Patient names and identifiers
• Manufacturing batch records only

Correct Answer: Relevant preclinical and clinical safety and efficacy information about the investigational product

Q28. After an audit identifies a root cause for repeated reporting errors, the correct response is to implement:

• Corrective and Preventive Actions (CAPA)
• Only a verbal warning to staff
• Immediate termination of the trial without investigation
• An advertising campaign

Correct Answer: Corrective and Preventive Actions (CAPA)

Q29. Which plan describes safety measures, signal detection strategy and risk minimization activities for a medicinal product?

• Risk Management Plan (RMP)
• Investigator’s salary plan
• Clinical supply distribution plan
• Marketing launch checklist

Correct Answer: Risk Management Plan (RMP)

Q30. What is EudraVigilance?

• The European database for suspected adverse reactions to medicines that are authorized or being studied in clinical trials
• A clinical trial recruitment website only
• A manufacturing compliance database
• An internal sponsor-only spreadsheet

Correct Answer: The European database for suspected adverse reactions to medicines that are authorized or being studied in clinical trials

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