WHO Adverse Reaction Terminology (WHO-ART) MCQs With Answer

WHO Adverse Reaction Terminology (WHO-ART) MCQs With Answer is a focused review designed for B. Pharm students to strengthen pharmacovigilance skills. WHO-ART is a standardized coding system for classifying adverse drug reactions (ADRs) used in safety reporting, signal detection, and regulatory submissions. This set covers WHO-ART structure, System Organ Classes, preferred and included terms, coding rules, advantages, and limitations compared with MedDRA, plus case classification and data management principles. Questions emphasize ADR identification, causality, seriousness, coding best practices, and interpretation of safety data. Clear explanations will improve competence in ADR monitoring, reporting, and drug safety assessment. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of the WHO Adverse Reaction Terminology (WHO-ART)?

• To provide dosing guidelines for drugs
• To standardize coding of adverse drug reactions for safety reporting
• To replace clinical trial protocols
• To classify drug pricing categories

Correct Answer: To standardize coding of adverse drug reactions for safety reporting

Q2. Which of the following best describes a “Preferred Term” in WHO-ART?

• A high-level aggregate term grouping multiple system organ classes
• The most specific standardized term used to represent an adverse reaction
• A proprietary drug name used in reporting
• An administrative code for regulatory agencies

Correct Answer: The most specific standardized term used to represent an adverse reaction

Q3. In pharmacovigilance, coding ADRs using WHO-ART improves which key activity?

• Manufacturing efficiency
• Signal detection and aggregated safety analysis
• Patient consent procedures
• Clinical trial randomization

Correct Answer: Signal detection and aggregated safety analysis

Q4. Which element is NOT typically part of an Individual Case Safety Report (ICSR) relevant to WHO-ART coding?

• Adverse event description
• Patient demographics
• Batch manufacturing procedure
• Suspected drug name and dose

Correct Answer: Batch manufacturing procedure

Q5. When a reporter writes “severe headache,” how should WHO-ART coding generally proceed?

• Code only “severe” as a term
• Code the clinical condition as “headache” and capture severity in seriousness or clinical details
• Ignore the report because it is subjective
• Code it as a new term without mapping

Correct Answer: Code the clinical condition as “headache” and capture severity in seriousness or clinical details

Q6. Which statement correctly contrasts WHO-ART with MedDRA?

• WHO-ART has a larger term set and international regulatory acceptance than MedDRA
• MedDRA is more granular and widely adopted in modern regulatory submissions than WHO-ART
• WHO-ART is exclusively used for veterinary products while MedDRA is for humans
• MedDRA lacks hierarchy while WHO-ART has detailed hierarchical levels

Correct Answer: MedDRA is more granular and widely adopted in modern regulatory submissions than WHO-ART

Q7. Which coding principle is important when selecting a WHO-ART term for an ADR?

• Always select the broadest available term
• Select the term that best represents the reported clinical concept
• Prefer terms that match the suspected drug brand name
• Choose terms alphabetically to ensure consistency

Correct Answer: Select the term that best represents the reported clinical concept

Q8. What role does WHO-ART play in causality assessment of ADRs?

• It provides the causality score automatically
• It standardizes the event terminology to support causality review
• It determines whether a drug is withdrawn from market
• It replaces clinical judgment in causality decisions

Correct Answer: It standardizes the event terminology to support causality review

Q9. Which is a limitation of WHO-ART that B. Pharm students should be aware of?

• It is too permissive and allows any text entry
• It has less granularity and fewer terms compared to MedDRA
• It enforces mandatory patient follow-up
• It includes only laboratory test results

Correct Answer: It has less granularity and fewer terms compared to MedDRA

Q10. When mapping a free-text report to WHO-ART, what is the first step?

• Calculate reporting rates
• Extract the clinical concept and context from the narrative
• Translate the whole report into another language
• Assign seriousness before coding

Correct Answer: Extract the clinical concept and context from the narrative

Q11. Which WHO-ART classification level groups related preferred terms under organ system headings?

• Signal Detection Level
• System Organ Class
• Product Class
• Regulatory Category

Correct Answer: System Organ Class

Q12. In routine pharmacovigilance databases using WHO-ART, aggregated term counts are used primarily to:

• Determine manufacturing costs
• Identify disproportional reporting and potential safety signals
• Replace causality assessment
• Generate patient prescriptions

Correct Answer: Identify disproportional reporting and potential safety signals

Q13. Which of the following is a recommended practice when coding multiple symptoms from one report?

• Code only the most severe symptom and ignore others
• Code all clinically relevant terms separately
• Combine all symptoms into one nonspecific term
• Submit only the drug information without event details

Correct Answer: Code all clinically relevant terms separately

Q14. How does WHO-ART support regulatory reporting obligations?

• By providing standardized ADR terminology that regulators can interpret consistently
• By generating automatic regulatory approval letters
• By determining pricing and reimbursement decisions
• By encrypting patient identifiers

Correct Answer: By providing standardized ADR terminology that regulators can interpret consistently

Q15. Which term best describes an ADR that results in death, life-threatening condition, hospitalization, disability or congenital anomaly?

• Expected event
• Serious adverse event
• Non-serious adverse event
• Pharmaceutical impurity

Correct Answer: Serious adverse event

Q16. When comparing two reports coded differently for similar events, what is a key step in signal evaluation?

• Ignore coding differences and count reports as identical
• Review narratives and recode if necessary to ensure comparable terms
• Delete the older report
• Only consider reports from the same country

Correct Answer: Review narratives and recode if necessary to ensure comparable terms

Q17. Which data element is most critical to capture alongside WHO-ART coding for effective pharmacovigilance analysis?

• Patient’s education level
• Time to onset of the reaction after drug exposure
• Drug manufacturing plant location
• Prescriber’s salary details

Correct Answer: Time to onset of the reaction after drug exposure

Q18. What is a recommended approach if a reported term has no direct match in WHO-ART?

• Invent a new term and use it consistently
• Choose the closest appropriate existing term and document the rationale
• Leave the event uncoded
• Code it as “unknown” for all analyses

Correct Answer: Choose the closest appropriate existing term and document the rationale

Q19. Why is consistent use of WHO-ART important across different reporters and centers?

• It minimizes the need for clinical review
• It ensures comparable aggregated data for monitoring and signal detection
• It reduces drug efficacy
• It speeds up clinical trials

Correct Answer: It ensures comparable aggregated data for monitoring and signal detection

Q20. Which practice helps maintain coding quality in a pharmacovigilance center using WHO-ART?

• Randomly change terms to avoid pattern detection
• Provide regular coder training and maintain a coding guideline
• Only allow physicians to enter codes without training
• Remove narratives after initial coding to save space

Correct Answer: Provide regular coder training and maintain a coding guideline

Q21. In regulatory submissions, mapping WHO-ART terms to MedDRA may be necessary because:

• MedDRA is required by many modern regulators and is more granular
• WHO-ART is not suitable for any regulatory use
• MedDRA contains pricing information
• WHO-ART terms are proprietary and cannot be shared

Correct Answer: MedDRA is required by many modern regulators and is more granular

Q22. Which of the following best defines an “Included Term” in WHO-ART?

• A synonym or variant expression mapped under a Preferred Term
• A term used only for administrative purposes
• A term indicating drug manufacturing defects
• A regulatory action code

Correct Answer: A synonym or variant expression mapped under a Preferred Term

Q23. How should severity and seriousness be recorded when coding with WHO-ART?

• Severity is encoded as a WHO-ART term; seriousness is captured in the case report fields
• Both are ignored because WHO-ART handles only terms
• Severity determines the WHO-ART Preferred Term
• Only seriousness is relevant; severity is never important

Correct Answer: Severity is encoded as a WHO-ART term; seriousness is captured in the case report fields

Q24. What is a common use of WHO-ART coded data beyond signal detection?

• Determining drug market price
• Generating safety summaries and aggregate reports for regulators
• Designing new drug formulations
• Managing hospital staffing schedules

Correct Answer: Generating safety summaries and aggregate reports for regulators

Q25. Which approach improves inter-rater reliability when multiple coders use WHO-ART?

• Allow each coder to use personal shortcuts
• Use a shared coding manual, examples, and periodic concordance exercises
• Avoid documenting coding decisions
• Only senior staff should code without oversight

Correct Answer: Use a shared coding manual, examples, and periodic concordance exercises

Q26. In a case where an ADR evolves (e.g., rash progressing to Stevens-Johnson syndrome), how should coding be handled?

• Code only the initial mild term to avoid duplication
• Update or add terms to reflect the most severe or current clinical condition, with dates
• Delete the initial entry once progression occurs
• Ignore progression and keep the first report unchanged

Correct Answer: Update or add terms to reflect the most severe or current clinical condition, with dates

Q27. Which metric calculated from WHO-ART coded data helps prioritize signals for review?

• Country GDP
• Reporting frequency or disproportionality measures (e.g., PRR)
• Therapeutic class price index
• Number of hospitals in a region

Correct Answer: Reporting frequency or disproportionality measures (e.g., PRR)

Q28. Which training topic is most important for new pharmacovigilance coders working with WHO-ART?

• How to manufacture drugs
• Clinical terminology, coding rules, and use of case narratives
• Medical billing procedures
• Marketing strategies for pharmaceuticals

Correct Answer: Clinical terminology, coding rules, and use of case narratives

Q29. If an ADR report lacks temporal information (time to onset), how does this affect WHO-ART-based analysis?

• It has no effect on any analysis
• It limits causality assessment and accurate signal evaluation
• It invalidates the WHO-ART coding completely
• It automatically classifies the event as non-serious

Correct Answer: It limits causality assessment and accurate signal evaluation

Q30. For research or regulatory review, what documentation should accompany WHO-ART coded datasets?

• Coding conventions, mapping notes, version of WHO-ART used, and glossary of terms
• Only the final aggregated counts without metadata
• Marketing plans and sales forecasts
• Clinical trial randomization lists

Correct Answer: Coding conventions, mapping notes, version of WHO-ART used, and glossary of terms

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