Terminologies and regulatory aspects of pharmacovigilance MCQs With Answer

Terminologies and regulatory aspects of pharmacovigilance MCQs With Answer

This quiz collection is designed for M.Pharm students preparing for advanced topics in clinical research and pharmacovigilance. It focuses on core terminologies, key concepts in signal detection, causality assessment, reporting requirements, regulatory timelines and global pharmacovigilance systems. Each question aims to deepen conceptual understanding and prepare students for both exams and professional responsibilities in safety surveillance. Questions include practical scenarios, regulatory frameworks (ICH/GVP concepts), reporting formats and pharmacovigilance documentation. Use these MCQs to test, revise and strengthen knowledge essential for managing drug safety, regulatory submissions and effective risk–benefit evaluation in a real-world pharmacovigilance setting.

Q1. What is the most accurate definition of pharmacovigilance?

• The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems
• The process of marketing and promoting medicinal products to healthcare professionals
• The laboratory testing of drug potency and stability
• The study of drug absorption, distribution, metabolism and excretion

Correct Answer: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems

Q2. Which statement correctly distinguishes an adverse event (AE) from an adverse drug reaction (ADR)?

• An AE implies a confirmed causal relationship with the drug, while an ADR is any symptom occurring after drug use without causal link
• An AE is any untoward medical occurrence temporally associated with drug use, whereas an ADR is a noxious and unintended response with at least a reasonable causal relationship to the drug
• An AE refers only to laboratory abnormalities, while ADRs refer only to clinical signs

Correct Answer: An AE is any untoward medical occurrence temporally associated with drug use, whereas an ADR is a noxious and unintended response with at least a reasonable causal relationship to the drug

Q3. Which item is NOT a typical mandatory data element of an individual case safety report (ICSR)?

• Suspected medicinal product name and dose
• Adverse event term and onset date
• Patient identifiable information and demographics
• The storage temperature of the investigational medicinal product during shipment

Correct Answer: The storage temperature of the investigational medicinal product during shipment

Q4. What is the primary purpose of MedDRA in pharmacovigilance?

• Provide a standardized, multilingual medical terminology for coding adverse events and regulatory reporting
• Assign chemical structure identifiers to active substances
• Standardize laboratory unit conversions across trials
• Replace all national pharmacopoeias for drug quality

Correct Answer: Provide a standardized, multilingual medical terminology for coding adverse events and regulatory reporting

Q5. How is a pharmacovigilance “signal” best described?

• An established causal relationship proven by a randomized controlled trial
• An indicator of a new or changing safety issue, that is a hypothesis of a causal association between a drug and an adverse event, requiring further investigation
• A routine laboratory value measured during safety monitoring
• A marketing claim approved by regulatory authorities

Correct Answer: An indicator of a new or changing safety issue, that is a hypothesis of a causal association between a drug and an adverse event, requiring further investigation

Q6. Which causality assessment method uses descriptive categorical terms such as “certain”, “probable/likely”, “possible” and “unassessable”?

• Naranjo algorithm (score-based)
• WHO-UMC causality assessment system (categorical)
• Bayesian disproportionality method
• Proportional reporting ratio (PRR)

Correct Answer: WHO-UMC causality assessment system (categorical)

Q7. According to ICH guidelines for clinical trial reporting, what are the standard expedited SUSAR reporting timelines for sponsors?

• Initial report for fatal or life‑threatening SUSARs within 7 calendar days and for other SUSARs within 15 calendar days
• All SUSARs must be reported within 30 days
• Fatal SUSARs within 24 hours and non-fatal within 3 days
• No expedited reporting is required for SUSARs during clinical development

Correct Answer: Initial report for fatal or life‑threatening SUSARs within 7 calendar days and for other SUSARs within 15 calendar days

Q8. Which of the following is NOT considered a criterion for a “serious” adverse event in regulatory pharmacovigilance?

• Results in death
• Requires inpatient hospitalization or prolongation of existing hospitalization
• Is a medically important condition (e.g., risk of permanent disability)
• A mild, self‑limiting headache that resolves without treatment

Correct Answer: A mild, self‑limiting headache that resolves without treatment

Q9. Which regulatory aggregate safety report has replaced the traditional PSUR concept under ICH E2C(R2) principles?

• Periodic Benefit‑Risk Evaluation Report (PBRER)
• Clinical Trial Application (CTA)
• Development Safety Update Report (DSUR)
• Single Case Report (SCR)

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

Q10. Who is primarily responsible for establishing and maintaining a pharmacovigilance system for a marketed medicinal product?

• The prescribing physician
• The marketing authorization holder (MAH) or sponsor
• The patient support group
• The advertising agency promoting the product

Correct Answer: The marketing authorization holder (MAH) or sponsor

Q11. The Pharmacovigilance System Master File (PSMF) typically contains:

• A detailed description of the pharmacovigilance system, SOPs, qualified persons and a list of local PV activities
• Complete raw clinical trial source documents for all studies
• Commercial sales forecasts and marketing strategies
• Only the contact details of physicians reporting ADRs

Correct Answer: A detailed description of the pharmacovigilance system, SOPs, qualified persons and a list of local PV activities

Q12. What is the CIOMS form used for in pharmacovigilance?

• An internationally harmonized form for reporting individual case safety reports (ICSRs) and facilitating expedited safety communication
• A template for clinical study protocols only
• A marketing authorization application checklist
• A laboratory test result sheet for toxicology

Correct Answer: An internationally harmonized form for reporting individual case safety reports (ICSRs) and facilitating expedited safety communication

Q13. Which of the following is NOT a routine step in pharmacovigilance signal management?

• Signal detection and validation
• Signal confirmation, analysis and prioritization
• Regulatory risk‑minimization measure implementation and communication
• Adjustment of drug chemical synthesis procedures in the manufacturing plant

Correct Answer: Adjustment of drug chemical synthesis procedures in the manufacturing plant

Q14. EudraVigilance is best described as:

• The European database for suspected adverse drug reaction reports and a tool for centralised signal detection and reporting
• An international pharmacopoeia for drug quality standards
• A clinical trial recruitment platform in Europe
• A commercial adverse event analytics software only for industry use

Correct Answer: The European database for suspected adverse drug reaction reports and a tool for centralised signal detection and reporting

Q15. Which method is commonly used in spontaneous reporting databases for disproportionality-based signal detection?

• Proportional Reporting Ratio (PRR)
• Randomized control trial meta‑analysis
• High‑performance liquid chromatography (HPLC)
• Double‑blind crossover design

Correct Answer: Proportional Reporting Ratio (PRR)

Q16. Which statement correctly contrasts expedited (individual) reporting and periodic aggregate safety reporting?

• Expedited reporting transmits single serious and unexpected case reports rapidly; periodic aggregate reports (e.g., PBRER) provide a structured cumulative evaluation of benefit–risk over a defined interval
• Periodic aggregate reports replace the need for any expedited reporting
• Expedited reports are only required for non‑serious events and periodic reports for serious events
• Both report types are identical in content and timing

Correct Answer: Expedited reporting transmits single serious and unexpected case reports rapidly; periodic aggregate reports (e.g., PBRER) provide a structured cumulative evaluation of benefit–risk over a defined interval

Q17. One principal objective of pharmacovigilance inspections by regulatory authorities is to:

• Verify that the marketing authorization holder’s pharmacovigilance system and practices comply with applicable laws, regulations and Good Pharmacovigilance Practices (GVP)
• Evaluate the product’s market share and sales performance
• Approve clinical trial protocols for new indications
• Audit the company’s financial accounts

Correct Answer: Verify that the marketing authorization holder’s pharmacovigilance system and practices comply with applicable laws, regulations and Good Pharmacovigilance Practices (GVP)

Q18. In India, what does PvPI stand for and what is its primary role?

• Pharmacovigilance Programme of India — to monitor drug safety, collect ICSRs and strengthen national adverse event reporting
• Private Pharmacy Initiative — a marketing body for private pharmacies
• Pharmaceutical Value Pricing Institute — to set drug prices
• Patient Vaccine Program International — to distribute vaccines abroad

Correct Answer: Pharmacovigilance Programme of India — to monitor drug safety, collect ICSRs and strengthen national adverse event reporting

Q19. What is the FDA “MedWatch” system?

• The US Food and Drug Administration’s safety information and adverse event reporting program for healthcare professionals, patients and consumers
• A database for clinical trial eligibility screening only
• An international regulatory body overseeing all drug approvals worldwide
• A pharmacovigilance inspection checklist used by the EMA

Correct Answer: The US Food and Drug Administration’s safety information and adverse event reporting program for healthcare professionals, patients and consumers

Q20. Which statement best reflects current good practice regarding patient identifiable information in pharmacovigilance reporting?

• ICSRs should include only the minimum necessary identifiable data and be handled securely and in accordance with applicable data protection and confidentiality laws; pseudonymisation or limited identifiers are used where possible
• All ICSRs must always include full unredacted personal identifiers and be freely published online
• Identifiable patient data are never permitted in any regulatory safety report
• Data protection laws do not apply to safety reporting, so no special measures are required

Correct Answer: ICSRs should include only the minimum necessary identifiable data and be handled securely and in accordance with applicable data protection and confidentiality laws; pseudonymisation or limited identifiers are used where possible

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