Methods of ADR reporting: spontaneous and active surveillance MCQs With Answer

Introduction: This quiz collection covers methods of ADR reporting — spontaneous and active surveillance — aimed at M.Pharm students studying Clinical Research and Pharmacovigilance. It explains principles, strengths, limitations, and practical applications of both approaches, and tests knowledge on signal detection, data sources, reporting formats, and hybrid methods like targeted spontaneous reporting. Questions focus on comparing passive versus active systems, common active designs (cohort event monitoring, prescription-event monitoring, registries), analytical tools (disproportionality), and operational issues such as under‑reporting, data quality, and regulatory roles. Each question includes clear options and answers to support rapid review and self‑assessment.

Q1. What best defines spontaneous (passive) ADR reporting?

• Systematic collection of ADRs using pre-defined cohorts and active follow-up
• Voluntary unsolicited reporting of suspected ADRs by healthcare professionals or consumers
• Routine extraction of ADRs from electronic health records using algorithms
• Mandatory periodic safety update reports from marketing authorization holders

Correct Answer: Voluntary unsolicited reporting of suspected ADRs by healthcare professionals or consumers

Q2. What is the primary objective of spontaneous ADR reporting systems?

• To estimate precise incidence rates of known adverse events
• To provide randomized evidence of causality for adverse effects
• Early detection of new, rare, or unexpected adverse drug reactions (signal generation)
• To replace clinical trials for drug safety evaluation

Correct Answer: Early detection of new, rare, or unexpected adverse drug reactions (signal generation)

Q3. Which limitation is most commonly associated with spontaneous reporting?

• High cost and intensive resource needs
• Requirement for predefined denominators
• Under‑reporting and reporting bias (stimulated or selective reporting)
• Inability to detect rare events

Correct Answer: Under‑reporting and reporting bias (stimulated or selective reporting)

Q4. Which characteristic distinguishes active surveillance from spontaneous reporting?

• Relies only on voluntary submissions by clinicians
• Is retrospective and passive in nature
• Systematic, proactive collection of ADR data with known denominator to estimate incidence
• Cannot provide follow-up information on cases

Correct Answer: Systematic, proactive collection of ADR data with known denominator to estimate incidence

Q5. Which of the following is an example of an active surveillance method?

• Spontaneous case reports submitted to a national PV centre
• Cohort event monitoring (CEM) following a defined group of exposed patients
• Voluntary patient complaints recorded in pharmacy logs
• Case series published in clinical journals

Correct Answer: Cohort event monitoring (CEM) following a defined group of exposed patients

Q6. What is targeted spontaneous reporting (TSR)?

• A fully automated signal detection algorithm applied to EHRs
• A focused form of spontaneous reporting for particular medicines, settings, or populations
• A randomized safety study conducted before marketing approval
• A mandatory industry-led registry for all marketed products

Correct Answer: A focused form of spontaneous reporting for particular medicines, settings, or populations

Q7. Which surveillance approach provides the best data to calculate incidence rates for ADRs?

• Spontaneous reporting database analysis
• Active surveillance methods (e.g., cohort event monitoring) with known denominators
• Case reports published in literature without denominator data
• Cross-sectional physician surveys asking for opinions

Correct Answer: Active surveillance methods (e.g., cohort event monitoring) with known denominators

Q8. What is the principal data product submitted in spontaneous reporting systems?

• Aggregate safety summary reports only
• Individual Case Safety Reports (ICSRs) from healthcare professionals and patients
• Pre-specified cohort datasets with full denominators
• Randomized controlled trial adverse event listings

Correct Answer: Individual Case Safety Reports (ICSRs) from healthcare professionals and patients

Q9. Which global repository aggregates spontaneous ADR reports from national centres?

• ClinicalTrials.gov
• VigiBase maintained by the Uppsala Monitoring Centre (UMC)
• PubMed Central
• European Medicines Agency’s XEVMPD

Correct Answer: VigiBase maintained by the Uppsala Monitoring Centre (UMC)

Q10. Which analytical technique is commonly used to detect disproportional reporting signals in spontaneous databases?

• Kaplan‑Meier survival analysis
• Disproportionality analysis (e.g., Proportional Reporting Ratio, Reporting Odds Ratio)
• Double‑blind randomized comparison
• Logistic regression without considering background rates

Correct Answer: Disproportionality analysis (e.g., Proportional Reporting Ratio, Reporting Odds Ratio)

Q11. Which ethical advantage is associated with active surveillance studies?

• They always require no informed consent
• They allow systematic follow-up, better outcome ascertainment, and pre-defined safety monitoring under oversight
• They prevent any selection bias by design
• They remove the need for data protection safeguards

Correct Answer: They allow systematic follow-up, better outcome ascertainment, and pre-defined safety monitoring under oversight

Q12. Compared to spontaneous reporting, active surveillance is generally:

• Less resource-intensive and cheaper
• More prone to under-reporting bias
• More resource-intensive and costly but yields higher completeness and denominators
• Unable to detect new safety signals

Correct Answer: More resource-intensive and costly but yields higher completeness and denominators

Q13. Which strategy directly addresses under-reporting in passive systems?

• Relying solely on literature case reports
• Implementing active surveillance methods or stimulated/targeted reporting campaigns
• Removing patient reporting options
• Reducing the number of data fields on reporting forms

Correct Answer: Implementing active surveillance methods or stimulated/targeted reporting campaigns

Q14. How can electronic health records (EHR) contribute to pharmacovigilance?

• They are irrelevant because they lack medication data
• EHR data mining supports active surveillance and signal detection through longitudinal patient-level data
• EHRs only store billing codes and cannot be used for ADR tasks
• They automatically replace the need for spontaneous reporting

Correct Answer: EHR data mining supports active surveillance and signal detection through longitudinal patient-level data

Q15. Which is an example of targeted spontaneous reporting?

• Randomized placebo-controlled safety trial
• Monitoring ADRs for antiretroviral therapy within a national HIV treatment program
• VigiBase global disproportionality analysis
• Retrospective cohort study using administrative claims data

Correct Answer: Monitoring ADRs for antiretroviral therapy within a national HIV treatment program

Q16. What does “stimulated reporting” mean in pharmacovigilance?

• Mandatory legal penalties for non-reporting
• Actions such as education, reminders, or campaigns to increase spontaneous reporting temporarily
• Automatically generating reports from manufacturing data
• Replacing active surveillance with spontaneous reporting

Correct Answer: Actions such as education, reminders, or campaigns to increase spontaneous reporting temporarily

Q17. Which metric is commonly used to judge the quality of an ICSR?

• Number of pages in the report only
• Completeness or quality score (clinical detail, time to onset, outcome, dechallenge/rechallenge)
• Whether the reporter is a pharmacist only
• Existence of a follow-up study without clinical details

Correct Answer: Completeness or quality score (clinical detail, time to onset, outcome, dechallenge/rechallenge)

Q18. Which regulatory purpose is best served by spontaneous ADR reporting?

• Providing definitive incidence estimates for labeling changes
• Post-marketing surveillance and early signal generation for rare or unexpected ADRs
• Conducting efficacy assessments for new indications
• Replacing pre‑clinical safety testing

Correct Answer: Post-marketing surveillance and early signal generation for rare or unexpected ADRs

Q19. Which active surveillance design is commonly used to monitor vaccine safety post‑authorization?

• Spontaneous reporting only to national PV centres
• Cohort event monitoring or enhanced active follow-up registries for defined vaccine recipients
• Case reports published by single clinicians
• Marketing claims analysis without clinical validation

Correct Answer: Cohort event monitoring or enhanced active follow-up registries for defined vaccine recipients

Q20. What is a practical limitation of active surveillance programmes?

• They invariably suffer extreme under-reporting compared with spontaneous schemes
• Higher cost, greater logistic complexity, and sometimes limited generalizability compared with passive systems
• They never provide denominators for rate calculations
• They cannot provide clinically validated outcomes

Correct Answer: Higher cost, greater logistic complexity, and sometimes limited generalizability compared with passive systems

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