Volume 9A pharmacovigilance MCQs With Answer

Volume 9A Pharmacovigilance MCQs With Answer

Introduction: This collection of Volume 9A pharmacovigilance MCQs is designed specifically for M.Pharm students preparing for advanced clinical research and regulatory exams. The set focuses on core pharmacovigilance concepts — spontaneous reporting, signal detection, causality assessment, safety reporting timelines, regulatory documents (PBRER, RMP, PSMF), MedDRA coding, ICH guidelines and database systems like VigiBase. Questions emphasize practical application and regulatory relevance, encouraging deeper understanding beyond definitions. Each MCQ is followed by the correct answer to support rapid self-assessment and focused revision useful for academics, viva voce and regulatory exam preparation.

Q1. Which of the following best defines an Individual Case Safety Report (ICSR)?

• A comprehensive literature review of drug safety data
• A single report describing an adverse event in an identifiable patient related to one or more medicinal products
• An aggregate periodic safety report for a medicinal product
• A regulatory inspection report of a pharmacovigilance system

Correct Answer: A single report describing an adverse event in an identifiable patient related to one or more medicinal products

Q2. Which ICH guideline specifically addresses the electronic transmission standards for safety reports (ICSRs)?

• ICH E2A
• ICH E2B
• ICH E2C
• ICH E6

Correct Answer: ICH E2B

Q3. Which term describes a regulatory classification of an adverse event that results in death, is life‑threatening, requires hospitalization, causes disability or is a congenital anomaly?

• Severity
• Expectedness
• Seriousness
• Causality

Correct Answer: Seriousness

Q4. The main purpose of a Risk Management Plan (RMP) for a medicinal product is to:

• Provide the marketing price and distribution plan
• Outline identified and potential safety risks and planned pharmacovigilance and risk minimization activities
• Document manufacturing batch release procedures
• Present clinical trial statistical analysis plans

Correct Answer: Outline identified and potential safety risks and planned pharmacovigilance and risk minimization activities

Q5. Which database is maintained by the Uppsala Monitoring Centre and serves as the WHO global repository for ICSRs?

• EudraVigilance
• FAERS
• VigiBase
• MedWatch

Correct Answer: VigiBase

Q6. MedDRA is used in pharmacovigilance to:

• Standardize coding and terminology for adverse events and medical information
• Provide electronic transmission formats for ICSRs
• Replace clinical study reports
• Calculate disproportionality metrics

Correct Answer: Standardize coding and terminology for adverse events and medical information

Q7. Which of the following methods is a commonly used disproportionality measure in signal detection that compares the proportion of reports for an event with a drug to all reports for that event?

• Proportional Reporting Ratio (PRR)
• Naranjo Algorithm
• Kaplan–Meier estimator
• ANOVA

Correct Answer: Proportional Reporting Ratio (PRR)

Q8. Which document replaced the traditional Periodic Safety Update Report (PSUR) to include structured benefit–risk evaluation?

• Annual Safety Summary (ASS)
• Periodic Benefit‑Risk Evaluation Report (PBRER)
• Individual Case Safety Report (ICSR)
• Clinical Study Report (CSR)

Correct Answer: Periodic Benefit‑Risk Evaluation Report (PBRER)

Q9. Which agency or guidance requires maintenance of a Pharmacovigilance System Master File (PSMF) describing a company’s PV system?

• World Health Organization only
• European Union (EU) regulatory requirements
• U.S. FDA exclusively
• MedDRA Maintenance Organization

Correct Answer: European Union (EU) regulatory requirements

Q10. In clinical trial safety reporting, a SUSAR that is fatal or life‑threatening must be reported to regulatory authorities within:

• 72 hours
• 7 calendar days
• 30 calendar days
• 90 days

Correct Answer: 7 calendar days

Q11. The WHO‑UMC causality categories include terms such as certain, probable, possible and unlikely. These categories are most useful for:

• Quantitative disproportionality analysis
• Standardized qualitative causality assessment of individual cases
• Determining product pricing
• Designing clinical trial endpoints

Correct Answer: Standardized qualitative causality assessment of individual cases

Q12. Which statistical approach uses Bayesian shrinkage to stabilize disproportionality estimates in large spontaneous reporting databases?

• Empirical Bayes Geometric Mean (EBGM) / MGPS
• Chi‑square test without correction
• Linear regression
• Naranjo algorithm

Correct Answer: Empirical Bayes Geometric Mean (EBGM) / MGPS

Q13. What is the primary objective of signal management in pharmacovigilance?

• To monitor drug sales and marketing performance
• To detect, validate, and assess new or changing safety information that may impact product benefit–risk
• To prepare clinical study reports
• To code adverse events using MedDRA

Correct Answer: To detect, validate, and assess new or changing safety information that may impact product benefit–risk

Q14. Which of the following is NOT considered an essential element of a well‑documented ICSR?

• Patient identifiable information or unique patient identifier
• Detailed investigative site financial records
• Suspected drug name and dose
• Description of the adverse event with outcome and reporter details

Correct Answer: Detailed investigative site financial records

Q15. Good Pharmacovigilance Practices (GVP) in the EU primarily address:

• Manufacturing quality control requirements
• Standards and processes for pharmacovigilance activities including signal detection, reporting, and risk minimization
• Clinical trial design and randomization procedures
• Pricing and reimbursement strategies

Correct Answer: Standards and processes for pharmacovigilance activities including signal detection, reporting, and risk minimization

Q16. Which of the following best describes ‘severity’ of an adverse reaction?

• A regulatory designation based on outcome (death, hospitalization, etc.)
• The intensity of the adverse event (mild, moderate, severe) regardless of outcome
• Whether the event is expected or unexpected
• The causality category assigned by WHO‑UMC

Correct Answer: The intensity of the adverse event (mild, moderate, severe) regardless of outcome

Q17. The Naranjo algorithm is primarily used to:

• Estimate disproportionality in spontaneous reports
• Assign a numerical score to assess the likelihood that a drug caused an adverse event
• Code medical terms using standardized terminology
• Determine reporting timelines for SUSARs

Correct Answer: Assign a numerical score to assess the likelihood that a drug caused an adverse event

Q18. Which of the following is an example of an aggregate safety report submitted periodically to regulatory authorities?

• Individual Case Safety Report (ICSR)
• Periodic Benefit‑Risk Evaluation Report (PBRER)
• Expedited SUSAR initial notification
• Clinical Investigator Brochure amendment

Correct Answer: Periodic Benefit‑Risk Evaluation Report (PBRER)

Q19. Disproportionality analysis compares observed reporting of a drug‑event pair to expected reporting. Which of the following is a commonly used frequentist disproportionality metric?

• Information Component (IC)
• Bayesian Confidence Propagation Neural Network (BCPNN)
• Reporting Odds Ratio (ROR)
• Empirical Bayes Geometric Mean (EBGM)

Correct Answer: Reporting Odds Ratio (ROR)

Q20. Which guideline specifically provides recommendations for handling clinical safety data, including expedited reporting requirements for serious adverse events in clinical trials?

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

Correct Answer: ICH E2A

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