Active surveillance – sentinel sites, drug event monitoring, registries MCQs With Answer

Active surveillance in pharmacovigilance is a proactive, systematic approach to drug safety that uses sentinel sites, drug event monitoring and patient registries to identify, evaluate and quantify adverse drug reactions (ADRs) after marketing. Sentinel sites gather detailed clinical and exposure data from selected hospitals or clinics; drug event monitoring (including cohort event monitoring and targeted spontaneous reporting) tracks incidence, patterns and risk factors; registries capture long-term outcomes and special population data. These systems enable signal detection, causality assessment, risk estimation, data mining (PRR, ROR, IC) and regulatory action. For B.Pharm students, mastering design, data elements, strengths/limitations and ethical reporting is essential for improving patient safety. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary goal of active surveillance in pharmacovigilance?

• To collect spontaneous reports from the general public
• To proactively and systematically detect adverse drug events after marketing
• To replace pre-marketing clinical trials
• To market new drugs to sentinel hospitals

Correct Answer: To proactively and systematically detect adverse drug events after marketing

Q2. Which of the following best describes a sentinel site?

• A random sample of patients on a drug without any clinical records
• A selected hospital or clinic providing detailed, high-quality safety data
• A social media platform used for adverse event discussion
• A national database of all marketed drugs

Correct Answer: A selected hospital or clinic providing detailed, high-quality safety data

Q3. Cohort event monitoring primarily focuses on which activity?

• Collecting spontaneous reports from healthcare professionals
• Following a defined group of patients exposed to a medicine to record all events
• Recording sales and prescription volumes only
• Randomized allocation of treatments

Correct Answer: Following a defined group of patients exposed to a medicine to record all events

Q4. Which data-mining measure is commonly used in active surveillance for signal detection?

• Number Needed to Treat (NNT)
• Proportional Reporting Ratio (PRR)
• Absolute risk reduction
• Kaplan-Meier estimate

Correct Answer: Proportional Reporting Ratio (PRR)

Q5. Registries in pharmacovigilance are most useful for studying:

• Short-term side effects only
• Long-term outcomes and rare events in defined populations
• Marketing strategies for new drugs
• Pre-clinical toxicology

Correct Answer: Long-term outcomes and rare events in defined populations

Q6. Targeted spontaneous reporting differs from routine spontaneous reporting because it:

• Requires randomization of subjects
• Focuses reporting from specific settings or for specific drugs or events
• Collects data only from social media
• Excludes serious adverse events

Correct Answer: Focuses reporting from specific settings or for specific drugs or events

Q7. Which causality assessment method is widely used in pharmacovigilance and is simple for routine use?

• Naranjo algorithm
• Kaplan-Meier method
• Cox proportional hazards
• ANOVA

Correct Answer: Naranjo algorithm

Q8. In sentinel site surveillance, data quality is primarily ensured by:

• Only accepting patient reports without verification
• Standardized case definitions, trained staff and regular audits
• Posting reminders on social media
• Using only billing data

Correct Answer: Standardized case definitions, trained staff and regular audits

Q9. Which coding dictionary is standard for adverse event terminology in pharmacovigilance registries?

• ICD-10 exclusively
• MedDRA
• SNOMED only
• DSM-5

Correct Answer: MedDRA

Q10. Drug event monitoring (DEM) aims to estimate which of the following?

• Marketing potential of a drug
• Incidence rates and temporal patterns of adverse events
• Preclinical toxicity in animals
• Patent expiry dates

Correct Answer: Incidence rates and temporal patterns of adverse events

Q11. Which of these is a limitation of registries?

• Ability to capture long-term outcomes
• Selection bias and incomplete follow-up
• Collection of detailed exposure data
• Useful for rare disease study

Correct Answer: Selection bias and incomplete follow-up

Q12. The information component (IC) is used in which pharmacovigilance database for disproportionality analysis?

• VigiBase
• Medline
• EMBASE
• ClinicalTrials.gov

Correct Answer: VigiBase

Q13. Which element is essential to collect in active surveillance to allow robust causality assessment?

• Sales revenue of the drug
• Temporal relationship between drug exposure and event
• Physician’s salary
• Number of doses sold

Correct Answer: Temporal relationship between drug exposure and event

Q14. Active surveillance complements passive surveillance by:

• Reducing the need for regulatory oversight
• Providing denominators and systematic follow-up for incidence estimation
• Only collecting marketing data
• Eliminating all reporting bias

Correct Answer: Providing denominators and systematic follow-up for incidence estimation

Q15. Which study design is commonly used in active surveillance to compare risk between exposed and unexposed groups?

• Cross-sectional survey only
• Cohort study
• Case report without comparator
• In vitro assay

Correct Answer: Cohort study

Q16. Target population registries are especially valuable for monitoring safety in:

• Healthy volunteers only
• Pediatrics, pregnancy and rare disease populations
• Animal studies
• Drug manufacturing plants

Correct Answer: Pediatrics, pregnancy and rare disease populations

Q17. Which of the following indicates a ‘signal’ in active surveillance?

• A single unverified social media post
• A reproducible increase in reporting or disproportionality for a specific drug-event pair
• A planned marketing campaign
• Stable background rates of a common event

Correct Answer: A reproducible increase in reporting or disproportionality for a specific drug-event pair

Q18. Ethical considerations in active surveillance include:

• Ignoring patient consent when collecting registry data
• Ensuring confidentiality, informed consent where required, and data security
• Selling patient data to advertisers
• Publishing identifiable patient photos without permission

Correct Answer: Ensuring confidentiality, informed consent where required, and data security

Q19. Which performance metric measures how often a suspected drug-event is confirmed as an ADR after investigation?

• Positive predictive value
• Drug price index
• Gross domestic product
• Median survival time

Correct Answer: Positive predictive value

Q20. In active surveillance, why is capture of denominator data important?

• It allows calculation of incidence rates and risk estimates
• It increases spontaneous report volume only
• It is needed to advertise drugs
• It replaces causality assessment

Correct Answer: It allows calculation of incidence rates and risk estimates

Q21. Which regulatory database is primarily used internationally for collecting individual case safety reports?

• VigiBase maintained by WHO Uppsala Monitoring Centre
• ClinicalTrials.gov only
• PubMed Central
• FDA Drug Trials Snapshots

Correct Answer: VigiBase maintained by WHO Uppsala Monitoring Centre

Q22. Which disproportionality metric estimates the odds of reporting a specific event for a drug compared to other drugs?

• Reporting Odds Ratio (ROR)
• Hazard Ratio from survival analysis
• Mean Difference
• Number Needed to Harm (NNH)

Correct Answer: Reporting Odds Ratio (ROR)

Q23. A sentinel surveillance system’s strength compared to national passive systems is:

• Complete capture of every adverse event nationwide
• High-quality, clinically validated data from defined populations
• No requirement for trained personnel
• Guaranteed absence of bias

Correct Answer: High-quality, clinically validated data from defined populations

Q24. Which factor can reduce under-reporting in active surveillance?

• Lack of training for site staff
• Regular active follow-up and simplified reporting tools
• Removing data quality checks
• Only relying on voluntary patient calls

Correct Answer: Regular active follow-up and simplified reporting tools

Q25. Quality indicators for a pharmacovigilance registry include:

• Completeness of core variables, follow-up rates and data validation
• Number of marketing emails sent
• Only including healthy subjects
• Frequency of social media posts

Correct Answer: Completeness of core variables, follow-up rates and data validation

Q26. Which of the following is a common trigger to start an active surveillance study?

• Legal disputes about patent rights
• Signals from spontaneous reporting suggesting a new safety concern
• Routine annual budgeting
• Holiday season in hospitals

Correct Answer: Signals from spontaneous reporting suggesting a new safety concern

Q27. Which type of analysis is used to adjust for confounding in cohort-based active surveillance?

• Multivariable regression
• Simple frequencies only
• Descriptive poetry
• Raw counts with no adjustments

Correct Answer: Multivariable regression

Q28. In pharmacovigilance registries, which unique identifier practice aids longitudinal follow-up while preserving privacy?

• Use of plaintext national ID in public reports
• Pseudonymization or coded unique identifiers
• Publishing full patient names
• Sharing identifiers with advertisers

Correct Answer: Pseudonymization or coded unique identifiers

Q29. Which describes targeted active surveillance?

• Surveillance limited to promotional events
• Focused monitoring of high-risk drugs, populations or events to improve detection
• Only collecting data from general population surveys
• Excluding regulatory authorities from data review

Correct Answer: Focused monitoring of high-risk drugs, populations or events to improve detection

Q30. After detecting a safety signal from active surveillance, the next recommended step is to:

• Immediately withdraw the drug without evaluation
• Verify and validate the signal, assess causality and quantify risk before regulatory action
• Publish the patient names on social media
• Ignore the signal if it is not profitable

Correct Answer: Verify and validate the signal, assess causality and quantify risk before regulatory action

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