Specialized resources for ADR data MCQs With Answer

Specialized resources for ADR data MCQs With Answer

This concise resource introduces B.Pharm students to specialized sources and tools for adverse drug reaction (ADR) data, covering pharmacovigilance databases, coding standards, signal detection methods, causality assessment, regulatory reporting, and data quality. Key topics include VigiBase, FAERS, EudraVigilance, MedDRA, WHODrug, disproportionality metrics (PRR, ROR, IC), Bayesian algorithms, Individual Case Safety Reports (ICSRs), SUSAR reporting timelines, and Periodic Benefit‑Risk Evaluation Reports (PBRER). Practical understanding of case processing, dechallenge/rechallenge, seriousness criteria, and confidentiality is emphasized to build drug safety competence. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the accepted definition of an adverse drug reaction (ADR) in pharmacovigilance?

• An expected side effect listed in the product pamphlet
• A harm related to medication errors only
• Any noxious and unintended response to a drug occurring at normal doses used in humans
• A beneficial therapeutic response to a drug

Correct Answer: Any noxious and unintended response to a drug occurring at normal doses used in humans

Q2. Which global database is maintained by the Uppsala Monitoring Centre for spontaneous ADR reports?

• FAERS
• VigiBase
• EudraVigilance
• MedWatch

Correct Answer: VigiBase

Q3. MedDRA is primarily used for which purpose in ADR data management?

• Coding medical terms for adverse events and diagnoses
• Assigning chemical structures to drugs
• Calculating disproportionality scores
• Encrypting patient identifiers

Correct Answer: Coding medical terms for adverse events and diagnoses

Q4. Which of the following is an Individual Case Safety Report (ICSR) essential data element?

• Manufacturing batch size
• Patient age and gender
• Company annual revenue
• Marketing strategy details

Correct Answer: Patient age and gender

Q5. Which disproportionality metric is abbreviated as PRR?

• Proportional Reporting Ratio
• Proportional Risk Regression
• Predictive Reporting Rate
• Probabilistic Risk Ratio

Correct Answer: Proportional Reporting Ratio

Q6. The Bayesian Confidence Propagation Neural Network (BCPNN) is associated with which organization’s signal detection work?

• World Health Organization / Uppsala Monitoring Centre
• European Medicines Agency
• Pharmaceutical manufacturers’ association
• National clinical trial registries

Correct Answer: World Health Organization / Uppsala Monitoring Centre

Q7. Which of the following is NOT a WHO‑UMC causality category?

• Certain
• Possible
• Probable/Likely
• Confirmed beyond doubt

Correct Answer: Confirmed beyond doubt

Q8. The Naranjo algorithm is principally used to assess what aspect of an ADR case?

• Financial impact of the ADR
• Causality between drug and reaction
• Quality of drug manufacturing
• Legal liability of prescribers

Correct Answer: Causality between drug and reaction

Q9. Which regulatory database is managed by the U.S. FDA for post‑marketing safety reports?

• VigiBase
• MedDRA
• FAERS
• EudraVigilance

Correct Answer: FAERS

Q10. In pharmacovigilance, which event is considered a criterion for seriousness?

• Mild transient headache resolving without treatment
• Hospitalization or prolonged hospitalization
• Temporary taste alteration without functional impact
• Expected injection‑site redness listed in the label

Correct Answer: Hospitalization or prolonged hospitalization

Q11. What does SUSAR stand for in clinical trial safety reporting?

• Serious Unexpected Special Adverse Result
• Suspected Unexpected Serious Adverse Reaction
• Standardized Urgent Safety Assessment Reporting
• Safety Update Summary and Annual Report

Correct Answer: Suspected Unexpected Serious Adverse Reaction

Q12. Which report has replaced the traditional PSUR under ICH E2C(R2) for periodic aggregated safety review?

• Risk Management Plan
• Periodic Benefit‑Risk Evaluation Report (PBRER)
• Monthly Safety Update Report
• Clinical Study Report

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

Q13. What is the role of WHODrug (or WHO Drug Dictionary) in ADR databases?

• Standardizing drug names and linking trade names to active ingredients
• Measuring disproportionality statistics
• Classifying adverse event seriousness
• Encrypting clinical trial data

Correct Answer: Standardizing drug names and linking trade names to active ingredients

Q14. Which of the following best describes ‘dechallenge’ in case assessment?

• Re‑exposing the patient to the drug to confirm causality
• Withdrawing the suspect drug and observing if the event abates
• Reporting the case to regulatory authorities immediately
• Applying a numerical causality score

Correct Answer: Withdrawing the suspect drug and observing if the event abates

Q15. What does the Information Component (IC) measure in disproportionality analysis?

• The absolute number of reports for a product
• A Bayesian measure of observed versus expected drug‑event combinations
• A pharmacokinetic parameter of drug exposure
• The legal risk of a signal

Correct Answer: A Bayesian measure of observed versus expected drug‑event combinations

Q16. Which system is the standard terminology for coding adverse event terms internationally?

• ICD‑10
• MedDRA
• SNOMED CT
• LOINC

Correct Answer: MedDRA

Q17. Which element must be removed or anonymized before submitting patient data to global ADR databases?

• Age group
• Gender
• Direct patient identifiers (name, national ID)
• Suspect drug name

Correct Answer: Direct patient identifiers (name, national ID)

Q18. Which of the following is a common data source for pharmacovigilance signal generation besides spontaneous reports?

• Clinical trial databases
• Marketing surveys unrelated to safety
• Internal sales forecasts
• Manufacturing equipment logs

Correct Answer: Clinical trial databases

Q19. What is the typical expedited reporting timeframe for a life‑threatening SUSAR in clinical trials to regulatory authorities?

• 30 calendar days
• 15 calendar days
• 7 calendar days
• 90 calendar days

Correct Answer: 7 calendar days

Q20. Reporting Odds Ratio (ROR) is used in pharmacovigilance to:

• Estimate the odds of a drug causing a specific event compared with other drugs in the database
• Determine the chemical structure of a drug
• Calculate the profitability of a medication
• Assess patient adherence patterns

Correct Answer: Estimate the odds of a drug causing a specific event compared with other drugs in the database

Q21. EudraVigilance is the centralized safety database for which regulatory body?

• U.S. Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• World Health Organization (WHO)
• Pharmaceutical industry trade groups

Correct Answer: European Medicines Agency (EMA)

Q22. Which of these best describes ‘signal validation’ in the signal management process?

• Automatically deleting duplicate reports
• Confirming whether a detected statistical alert represents a true, clinically meaningful safety concern
• Marketing the drug after approval
• Assigning MedDRA terms to events

Correct Answer: Confirming whether a detected statistical alert represents a true, clinically meaningful safety concern

Q23. Which coding classification groups drugs by therapeutic use and chemical characteristics with an anatomical perspective?

• ATC (Anatomical Therapeutic Chemical classification)
• ICSR
• CTCAE
• BCPNN

Correct Answer: ATC (Anatomical Therapeutic Chemical classification)

Q24. Which of the following is NOT a typical step in ICSR case processing?

• Data entry and validation
• Adverse event coding using MedDRA
• Causality assessment
• Manufacturing process optimization

Correct Answer: Manufacturing process optimization

Q25. A positive rechallenge provides what level of evidence for causality?

• No evidence; rechallenge is irrelevant
• Weak evidence because re‑exposure confounds results
• Strong evidence because the reaction recurs on re‑exposure
• Regulatory evidence to withdraw the drug immediately

Correct Answer: Strong evidence because the reaction recurs on re‑exposure

Q26. Which organization operates the MedWatch safety reporting program?

• European Medicines Agency
• Uppsala Monitoring Centre
• U.S. Food and Drug Administration
• World Health Organization

Correct Answer: U.S. Food and Drug Administration

Q27. Which type of report summarizes adverse reactions for marketed products on an ongoing periodic basis at the company level?

• Case report form
• Periodic Benefit‑Risk Evaluation Report (PBRER)
• Investigator brochure only
• Clinical trial protocol

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

Q28. Which statement about spontaneous reporting systems is TRUE?

• They provide exact incidence rates for ADRs in the population
• They are a primary source for early signal detection despite underreporting
• They always contain complete clinical and laboratory data
• They replace the need for post‑marketing studies

Correct Answer: They are a primary source for early signal detection despite underreporting

Q29. Which of the following best describes ‘expectedness’ of an ADR?

• Whether the ADR is listed in the current product information or label
• The speed with which the reaction develops
• The statistical significance of a signal
• The market share of the drug

Correct Answer: Whether the ADR is listed in the current product information or label

Q30. As a B.Pharm student participating in pharmacovigilance, which activity is most appropriate?

• Altering ICSR data to protect company image
• Ignoring suspected ADRs seen during clinical training
• Timely reporting and accurate documentation of suspected ADRs to the designated PV center
• Publishing patient identifiers in safety reports

Correct Answer: Timely reporting and accurate documentation of suspected ADRs to the designated PV center

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