Pharmacovigilance regulations and reporting guidelines MCQs With Answer

Pharmacovigilance regulations and reporting guidelines MCQs With Answer

Introduction: This quiz collection is designed for M.Pharm students specializing in Clinical Research and Pharmacovigilance. It covers essential global and national pharmacovigilance regulations, electronic reporting standards, timelines for expedited reporting, signal detection methods, required pharmacovigilance documents and roles, and key databases used for adverse event collection. Each question targets deeper understanding of regulatory expectations and practical reporting workflows used by sponsors, marketing authorisation holders and healthcare professionals. Practising these MCQs will help you prepare for examinations and real-world responsibilities such as SUSAR reporting, preparation of PBRERs, maintaining a PV system and interacting with systems like EudraVigilance, FAERS and VigiBase.

Q1. Which ICH guideline specifically addresses definitions and standards for expedited reporting of clinical safety data, including SUSARs?

• ICH E6 (Good Clinical Practice)
• ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting)
• ICH M4 (Common Technical Document)
• ICH E8 (General Considerations for Clinical Trials)

Correct Answer: ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting)

Q2. Under ICH expedited reporting, what is the initial reporting timeline for a fatal or life‑threatening SUSAR from the time the sponsor becomes aware?

• 24 hours
• 7 calendar days
• 15 calendar days
• 30 calendar days

Correct Answer: 7 calendar days

Q3. What does the abbreviation PBRER stand for in pharmacovigilance periodic reporting?

• Periodic Benefit-Risk Evaluation Report
• Periodic Biological Risk Evaluation Review
• Pharmacovigilance Benefit-Risk Event Register
• Post-marketing Biannual Risk Evaluation Report

Correct Answer: Periodic Benefit-Risk Evaluation Report

Q4. Which body is responsible for operating the EudraVigilance system?

• World Health Organization (WHO)
• European Medicines Agency (EMA)
• U.S. Food and Drug Administration (FDA)
• Uppsala Monitoring Centre (UMC)

Correct Answer: European Medicines Agency (EMA)

Q5. Which global database maintained by the Uppsala Monitoring Centre houses individual case safety reports submitted by national pharmacovigilance centres?

• FAERS
• EudraVigilance
• VigiBase
• MedWatch

Correct Answer: VigiBase

Q6. In the European Union pharmacovigilance system, the role responsible for overall pharmacovigilance oversight within a marketing authorisation holder is called:

• Qualified Person for Pharmacovigilance (QPPV)
• Pharmacovigilance Officer (PVO)
• Safety Data Coordinator (SDC)
• Regulatory Safety Lead (RSL)

Correct Answer: Qualified Person for Pharmacovigilance (QPPV)

Q7. Which document typically describes the pharmacovigilance system, responsibilities, processes and resources of a marketing authorisation holder?

• Clinical Study Protocol
• Pharmacovigilance System Master File (PV-MF)
• Investigator’s Brochure
• Regulatory Submission Dossier Module 3

Correct Answer: Pharmacovigilance System Master File (PV-MF)

Q8. Which ICH guideline provides the structure and content guidance for the periodic benefit-risk evaluation report (PBRER)?

• ICH E2C(R2)
• ICH E3
• ICH E4
• ICH S6

Correct Answer: ICH E2C(R2)

Q9. Which of the following is a commonly used statistical disproportionality method for signal detection in spontaneous reporting databases?

• Kaplan-Meier estimation
• Proportional Reporting Ratio (PRR)
• ANOVA analysis
• Cox proportional hazards model

Correct Answer: Proportional Reporting Ratio (PRR)

Q10. Which form is specifically intended by the US FDA for voluntary consumer reporting of adverse events?

• Form FDA 3500A
• Form FDA 3500B
• Form FDA 356h
• Form FDA 1572

Correct Answer: Form FDA 3500B

Q11. Which Indian programme is responsible for coordinating national pharmacovigilance activities including adverse drug reaction reports?

• Pharmacovigilance Programme of India (PvPI)
• National Adverse Event Reporting Initiative (NAERI)
• Indian Drug Safety Centre (IDSC)
• Central ADR Monitoring Board (CADRMB)

Correct Answer: Pharmacovigilance Programme of India (PvPI)

Q12. Which of the following best describes a Suspected Unexpected Serious Adverse Reaction (SUSAR)?

• An adverse reaction that is expected and non-serious
• A serious adverse reaction that is unexpected and for which there is a reasonable suspected causal relationship to the investigational product
• An adverse event unrelated to the investigational product
• A non-serious event previously listed in the Investigator’s Brochure

Correct Answer: A serious adverse reaction that is unexpected and for which there is a reasonable suspected causal relationship to the investigational product

Q13. Which guideline defines the electronic transmission standard for Individual Case Safety Reports (ICSRs)?

• ICH E2B
• ICH E1A
• ICH M2
• ICH S3

Correct Answer: ICH E2B

Q14. What is the main goal of a Risk Management Plan (RMP) for a medicinal product?

• To plan clinical trial recruitment strategies
• To describe identified and potential safety concerns and define pharmacovigilance activities and risk minimization measures
• To outline marketing and commercial distribution channels
• To replace periodic safety reporting

Correct Answer: To describe identified and potential safety concerns and define pharmacovigilance activities and risk minimization measures

Q15. Which adverse event reporting system is maintained by the U.S. FDA for post-marketing safety surveillance?

• VigiBase
• FAERS (FDA Adverse Event Reporting System)
• EudraVigilance
• PvPI ADR Database

Correct Answer: FAERS (FDA Adverse Event Reporting System)

Q16. According to common international practice, what is the usual expedited reporting timeline for a marketing authorisation holder to notify regulatory authorities of a serious and unexpected adverse reaction identified from global sources?

• Within 48 hours
• Within 15 calendar days
• Within 90 calendar days
• Within 6 months

Correct Answer: Within 15 calendar days

Q17. Which organization publishes the CIOMS forms and guidance relevant to case narrative reporting and international case transmission?

• Council for International Organizations of Medical Sciences (CIOMS)
• European Commission
• International Council for Harmonisation (ICH)
• World Bank

Correct Answer: Council for International Organizations of Medical Sciences (CIOMS)

Q18. Which definition best matches the WHO definition of an adverse drug reaction (ADR)?

• A therapeutic failure observed in a clinical trial
• A noxious and unintended response to a medicine that occurs at normal doses used in humans
• An expected pharmacological effect at recommended doses
• An intentional overdose administered for therapeutic benefit

Correct Answer: A noxious and unintended response to a medicine that occurs at normal doses used in humans

Q19. In signal management, which activity follows initial statistical detection of a disproportionality signal?

• Immediate market withdrawal of the product
• Validation and clinical assessment including case-level review and literature evaluation
• Automatic labelling change without review
• Closure of the safety database

Correct Answer: Validation and clinical assessment including case-level review and literature evaluation

Q20. Which of the following is a key responsibility of a Sponsor under clinical trial safety regulations?

• To perform routine batch release testing of investigational medicinal products
• To ensure timely collection, evaluation and expedited reporting of suspected unexpected serious adverse reactions (SUSARs) to investigators and competent authorities
• To market the investigational product during the trial
• To provide legal advice to investigators

Correct Answer: To ensure timely collection, evaluation and expedited reporting of suspected unexpected serious adverse reactions (SUSARs) to investigators and competent authorities

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