Pharmacovigilance is the science of detecting, assessing, understanding and preventing adverse drug reactions (ADRs) and other drug-related problems. In clinical trials, robust safety monitoring ensures participant protection, reliable signal detection, timely reporting of SAEs/SUSARs, and compliance with regulatory guidelines (ICH, CIOMS, E2B). B.Pharm students must learn causality assessment methods (WHO-UMC, Naranjo), risk management plans, MedDRA coding, expedited reporting timelines, Data Safety Monitoring Boards, and Periodic Safety Update Reports. This knowledge strengthens clinical trial conduct, pharmacovigilance practice, and future roles in drug safety and regulatory affairs. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the WHO definition of pharmacovigilance?
- The science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug-related problems
- The marketing strategies for promoting drug safety
- Only post-marketing surveillance of medicines
- The clinical development plan for a new drug
Correct Answer: The science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug-related problems
Q2. Which of the following best distinguishes an Adverse Event (AE) from an Adverse Drug Reaction (ADR)?
- AE requires a proven causal relationship with the drug, ADR does not
- AE is any untoward medical occurrence, ADR implies a suspected causal relationship with the drug
- ADR includes medication errors only, AE includes all events
- AE occurs only in clinical trials, ADR occurs only in post-marketing
Correct Answer: AE is any untoward medical occurrence, ADR implies a suspected causal relationship with the drug
Q3. Which of the following events is NOT typically classified as a Serious Adverse Event (SAE)?
- Hospitalization or prolongation of existing hospitalization
- Congenital anomaly or birth defect
- Transient mild headache resolving without intervention
- Life-threatening event
Correct Answer: Transient mild headache resolving without intervention
Q4. What does SUSAR stand for in clinical trial safety reporting?
- Serious Unsolicited Safety Assessment Report
- Suspected Unexpected Serious Adverse Reaction
- Systematic Unexpected Safety Assessment Record
- Safety Update Summary and Adverse Reaction
Correct Answer: Suspected Unexpected Serious Adverse Reaction
Q5. According to ICH guidance, what is the expedited reporting timeline for fatal or life‑threatening SUSARs?
- 72 hours
- 7 calendar days
- 30 calendar days
- 90 days
Correct Answer: 7 calendar days
Q6. Which causality assessment method uses categories like Certain, Probable, Possible, Unlikely?
- Naranjo algorithm
- WHO–UMC causality assessment system
- CTCAE grading scale
- MedDRA hierarchy
Correct Answer: WHO–UMC causality assessment system
Q7. Naranjo algorithm is primarily used to assess what?
- Severity grading of adverse events
- Causality probability score for ADRs
- Signal detection using disproportionality
- Quality of clinical trial monitoring
Correct Answer: Causality probability score for ADRs
Q8. Which coding dictionary is standard for coding adverse events in clinical trials and pharmacovigilance?
- ICD-10
- SNOMED CT
- MedDRA
- ATC only
Correct Answer: MedDRA
Q9. What is the primary role of a Data Safety Monitoring Board (DSMB) in a clinical trial?
- To market the investigational product
- To provide independent periodic review of safety and efficacy data and recommend trial continuation or modification
- To prepare the Investigator’s Brochure
- To code adverse events using MedDRA
Correct Answer: To provide independent periodic review of safety and efficacy data and recommend trial continuation or modification
Q10. Which report summarizes cumulative safety information periodically after marketing authorization?
- Investigator’s Brochure
- Periodic Safety Update Report (PSUR) / PBRER
- Case Report Form (CRF)
- Informed Consent Form
Correct Answer: Periodic Safety Update Report (PSUR) / PBRER
Q11. What is MedDRA primarily used for?
- Assessing causality of ADRs
- Standardized classification and coding of medical terms including adverse events
- Measuring drug plasma concentrations
- Calculating reporting odds ratios
Correct Answer: Standardized classification and coding of medical terms including adverse events
Q12. Which of the following is a common signal detection method in pharmacovigilance?
- Randomized controlled trials only
- Disproportionality analysis (e.g., PRR, ROR) on spontaneous reporting databases
- Manufacturer’s marketing survey
- Physician opinion polls
Correct Answer: Disproportionality analysis (e.g., PRR, ROR) on spontaneous reporting databases
Q13. What is an Investigator’s Brochure (IB)?
- A summary of preclinical and clinical data relevant to the study of an investigational product
- A weekly safety newsletter for patients
- Regulatory submission form for marketing approval
- A billing document for clinical trial expenses
Correct Answer: A summary of preclinical and clinical data relevant to the study of an investigational product
Q14. Which regulatory guidance specifies the electronic transmission format for Individual Case Safety Reports (ICSRs)?
- ICH E2B
- ICH E6(R2)
- ICH Q8
- WHO-UMC manual
Correct Answer: ICH E2B
Q15. Which element is essential when reporting a SUSAR to regulatory authorities?
- Detailed safety information including suspected drug, event description, and causality assessment
- Only the patient’s social history
- Marketing strategy to mitigate risk
- Full protocol of other unrelated studies
Correct Answer: Detailed safety information including suspected drug, event description, and causality assessment
Q16. Which of the following best describes a pharmacovigilance signal?
- A confirmed causal link between drug and event
- Information that suggests a new potentially causal association or a new aspect of a known association between an intervention and an event
- Only laboratory abnormalities detected in animals
- A marketing claim about drug safety
Correct Answer: Information that suggests a new potentially causal association or a new aspect of a known association between an intervention and an event
Q17. What does CIOMS commonly refer to in safety reporting?
- A standard form and working group for international safety reporting and case narrative guidance
- A statistical method for signal detection
- An adverse event severity grading system
- A brand name of a pharmacovigilance database
Correct Answer: A standard form and working group for international safety reporting and case narrative guidance
Q18. Which category in causality assessment suggests a temporal relationship and plausible response to withdrawal but requires rechallenge for confirmation?
- Certain
- Possible
- Unlikely
- Unassessable
Correct Answer: Certain
Q19. What is the main purpose of a Risk Management Plan (RMP) in pharmacovigilance?
- To outline safety monitoring activities and measures to minimize identified and potential risks of a drug
- To describe manufacturing procedures
- To advertise risk-benefit balance to consumers
- To list investigators involved in a trial
Correct Answer: To outline safety monitoring activities and measures to minimize identified and potential risks of a drug
Q20. Which database is a global spontaneous reporting system maintained by the WHO for monitoring drug safety?
- FAERS
- EudraVigilance
- VigiBase
- ClinicalTrials.gov
Correct Answer: VigiBase
Q21. What does PSUR stand for and why is it prepared?
- Periodic Safety Update Report; to provide cumulative safety data and benefit-risk evaluation post-authorization
- Pre-study Unified Report; to summarize study design
- Patient Safety Use Record; to log dosing instructions
- Post-marketing Surveillance Use Report; to list sales data
Correct Answer: Periodic Safety Update Report; to provide cumulative safety data and benefit-risk evaluation post-authorization
Q22. Expedited reporting of SUSARs must be sent to which parties in many jurisdictions?
- The trial sponsor, regulatory authorities, and ethics committees/institutional review boards
- Only the marketing department
- Only the trial participants
- Only international newspapers
Correct Answer: The trial sponsor, regulatory authorities, and ethics committees/institutional review boards
Q23. Which term refers to the unexpected worsening of a known drug-related adverse event in a trial?
- Expected adverse event
- Suspected unexpected serious adverse reaction (SUSAR)
- Non-serious AE
- Therapeutic failure only
Correct Answer: Suspected unexpected serious adverse reaction (SUSAR)
Q24. Which activity is part of active pharmacovigilance in clinical trials?
- Passive receipt of spontaneous reports only
- Prospective safety monitoring, scheduled follow-up and targeted surveillance of events
- Advertising drug benefits
- Financial auditing of trial sites
Correct Answer: Prospective safety monitoring, scheduled follow-up and targeted surveillance of events
Q25. What is the role of an Ethics Committee/Institutional Review Board (IEC/IRB) in safety monitoring?
- To ensure patient safety and that risks are minimized and promptly reported; to review safety reports and approve study conduct
- To market investigational products
- To manufacture the investigational drug
- To perform MedDRA coding
Correct Answer: To ensure patient safety and that risks are minimized and promptly reported; to review safety reports and approve study conduct
Q26. Which of the following is NOT a component of an Individual Case Safety Report (ICSR)?
- Patient demographic and clinical details
- Suspected drug information and event description
- Detailed batch manufacturing process of the drug
- Reporter information and causality assessment
Correct Answer: Detailed batch manufacturing process of the drug
Q27. In signal evaluation, which step follows signal detection?
- Signal prioritization and validation including review of case series and data sources
- Immediate market withdrawal without assessment
- Ignoring the signal until annual report
- Automatic causality confirmation
Correct Answer: Signal prioritization and validation including review of case series and data sources
Q28. Which grading system is commonly used to describe severity of adverse events in oncology trials (often used in clinical trials generally)?
- CTCAE (Common Terminology Criteria for Adverse Events)
- ICH E6 severity index
- WHO-UMC severity scale
- MedDRA severity code
Correct Answer: CTCAE (Common Terminology Criteria for Adverse Events)
Q29. Which statistical measure is commonly used in disproportionality analyses for signal detection?
- Relative risk from a randomized trial only
- Proportional Reporting Ratio (PRR) or Reporting Odds Ratio (ROR)
- Mean difference of laboratory values
- Kaplan-Meier survival estimate
Correct Answer: Proportional Reporting Ratio (PRR) or Reporting Odds Ratio (ROR)
Q30. What is an appropriate immediate action when a serious unexpected adverse reaction is detected in a blinded clinical trial?
- Ignore it until unblinding at study end
- Unblind if necessary for safety assessment and report as SUSAR per regulations while preserving trial integrity
- Publish the case in a journal without notifying authorities
- Terminate all related ongoing clinical trials worldwide immediately without assessment
Correct Answer: Unblind if necessary for safety assessment and report as SUSAR per regulations while preserving trial integrity
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com