Drug safety reporting and pharmacovigilance in trials MCQs With Answer

Drug safety reporting and pharmacovigilance in trials MCQs With Answer

This collection of MCQs is tailored for M.Pharm students studying Clinical Research (MPP 104T) to strengthen understanding of drug safety reporting and pharmacovigilance within clinical trials. Questions focus on regulatory requirements, definitions (AE, ADR, SAE, SUSAR), causality assessment methods, expedited reporting timelines, safety databases and coding (MedDRA), aggregate reports (DSUR, PBRER), signal detection techniques, and the roles of sponsor, investigator and DSMB. Designed to be challenging yet practical, the quiz emphasizes real-world responsibilities, correct documentation and decision-making in safety surveillance, preparing students to manage and interpret safety information during drug development.

Q1. What is the defining feature of a SUSAR in clinical trials?

• A serious adverse event that occurs frequently in the trial population
• An adverse event that is serious, unexpected and suspected to be caused by the investigational medicinal product
• An adverse event listed in the Investigator’s Brochure
• An adverse event that only requires aggregate reporting annually

Correct Answer: An adverse event that is serious, unexpected and suspected to be caused by the investigational medicinal product

Q2. Which timeline is commonly required for initial expedited reporting of a fatal or life‑threatening SUSAR to regulatory authorities?

• Within 24 hours
• Within 7 calendar days
• Within 30 calendar days
• Within 90 calendar days

Correct Answer: Within 7 calendar days

Q3. Which report is specifically intended as an annual safety update for an investigational product during clinical development?

• Periodic Benefit‑Risk Evaluation Report (PBRER)
• Development Safety Update Report (DSUR)
• Individual Case Safety Report (ICSR)
• Periodic Safety Update Report (PSUR) for marketed products only

Correct Answer: Development Safety Update Report (DSUR)

Q4. Which causality assessment method provides standardized qualitative categories such as “certain”, “probable” and “possible” widely used in pharmacovigilance?

• Naranjo algorithm
• WHO‑UMC causality assessment
• Bayesian disproportionality analysis
• Kaplan‑Meier causality test

Correct Answer: WHO‑UMC causality assessment

Q5. What is the main purpose of a Data Safety Monitoring Board (DSMB) during a clinical trial?

• To promote the sponsor’s commercial interests
• To independently monitor accumulating safety and efficacy data and recommend trial continuation or stopping
• To perform drug manufacturing quality control
• To recruit study participants at clinical sites

Correct Answer: To independently monitor accumulating safety and efficacy data and recommend trial continuation or stopping

Q6. Which of the following best describes an Individual Case Safety Report (ICSR)?

• An aggregate summary of all adverse events over a year
• A standardized record of a single patient’s adverse event associated with a medicinal product
• A report that only includes laboratory abnormalities
• A clinical trial protocol appendix

Correct Answer: A standardized record of a single patient’s adverse event associated with a medicinal product

Q7. Which coding dictionary is internationally accepted for standardizing adverse event terms in clinical trials and pharmacovigilance?

• SNOMED CT
• LOINC
• MedDRA
• ICD‑10

Correct Answer: MedDRA

Q8. Which of the following indicators is a disproportionality measure commonly used for signal detection in safety databases?

• Relative Risk Reduction (RRR)
• Proportional Reporting Ratio (PRR)
• Number Needed to Treat (NNT)
• Incidence Rate Ratio (IRR)

Correct Answer: Proportional Reporting Ratio (PRR)

Q9. In a blinded randomized trial, what is the sponsor’s obligation regarding unblinding for safety reporting purposes?

• The sponsor must never unblind under any circumstances
• The sponsor should unblind individual treatment for a suspected unexpected serious adverse reaction when necessary to report to regulators and investigators
• The sponsor should unblind all participants at interim analysis regardless of safety findings
• The sponsor only unblinds when requested by a single investigator

Correct Answer: The sponsor should unblind individual treatment for a suspected unexpected serious adverse reaction when necessary to report to regulators and investigators

Q10. Which element is NOT typically part of a complete ICSR?

• Patient demographics and medical history
• Description of the adverse event and outcome
• Detailed manufacturing batch release protocol
• Suspect drug information and concomitant medications

Correct Answer: Detailed manufacturing batch release protocol

Q11. Which statement best differentiates an Adverse Event (AE) from an Adverse Drug Reaction (ADR)?

• AE implies causality while ADR does not
• An AE is any untoward medical occurrence; an ADR is an AE with at least a reasonable suspicion of causal relationship to the drug
• ADR refers only to laboratory abnormalities
• AE is restricted to serious outcomes only

Correct Answer: An AE is any untoward medical occurrence; an ADR is an AE with at least a reasonable suspicion of causal relationship to the drug

Q12. Which document should list expected adverse reactions and is used to determine unexpectedness for expedited reporting?

• Investigator’s Brochure (IB)
• Case Report Form (CRF)
• Informed Consent Form (ICF)
• Clinical Study Protocol synopsis only

Correct Answer: Investigator’s Brochure (IB)

Q13. Which of the following is an essential component of a Risk Management Plan (RMP) for a new medicinal product?

• Marketing strategy and price forecast
• Identification of important identified and potential risks and planned risk minimization activities
• Only preclinical toxicology summaries
• Investigator personal contact details

Correct Answer: Identification of important identified and potential risks and planned risk minimization activities

Q14. Which regulatory report replaces PSUR for periodic benefit‑risk evaluation and is suitable for both marketed and investigational products under ICH guidance?

• DSUR
• PBRER
• ICSR
• Clinical Study Report (CSR)

Correct Answer: PBRER

Q15. Which of the following best describes “signal” in pharmacovigilance?

• A confirmed causal relationship between drug and event
• Information suggesting a new or changed causal association between an intervention and an event that warrants further evaluation
• A routine adverse event listed in the product label
• A statistical test that always proves causation

Correct Answer: Information suggesting a new or changed causal association between an intervention and an event that warrants further evaluation

Q16. Under ICH E2A/US FDA IND safety reporting, what is the typical timeframe for reporting non‑fatal, non‑life‑threatening suspected adverse reactions?

• Within 7 days
• Within 15 calendar days
• Within 48 hours
• Annually

Correct Answer: Within 15 calendar days

Q17. Which analysis is most appropriate for identifying time‑to‑onset patterns that may support a causal association between drug exposure and adverse events?

• Survival analysis / time‑to‑event analysis
• Cross‑sectional prevalence analysis
• Cost‑effectiveness analysis
• Meta‑regression of baseline demographics only

Correct Answer: Survival analysis / time‑to‑event analysis

Q18. Which action is expected of an investigator when a serious adverse event (SAE) occurs at their site?

• Ignore it if the subject recovers
• Report the SAE to the sponsor promptly and ensure participant safety measures are in place
• Only record it in the electronic medical record without notifying the sponsor
• Delay reporting until the end of the trial

Correct Answer: Report the SAE to the sponsor promptly and ensure participant safety measures are in place

Q19. Which factor would most strongly support a “certain” causality assessment under WHO‑UMC criteria?

• The event has multiple plausible alternative explanations
• The event follows a plausible temporal relationship, resolves on withdrawal (dechallenge) and recurs on re‑exposure (rechallenge)
• The event is common in the disease population and unrelated to drug timing
• The event cannot be assessed due to insufficient information

Correct Answer: The event follows a plausible temporal relationship, resolves on withdrawal (dechallenge) and recurs on re‑exposure (rechallenge)

Q20. Which repository is used in the EU for electronic exchange and maintenance of adverse reaction reports from EEA marketing authorization holders and clinical trial sponsors?

• FAERS (FDA Adverse Event Reporting System)
• EudraVigilance
• VigiBase
• WHO Clinical Trials Registry

Correct Answer: EudraVigilance

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