Pharmacovigilance databases and tools: Argus, ArisG, VigiFlow MCQs With Answer

Introduction: Pharmacovigilance databases and tools—such as Argus, ArisG, and VigiFlow—are central to modern drug safety operations. For M.Pharm students focusing on clinical research and pharmacovigilance, understanding these systems goes beyond basic definitions: it includes case intake and triage, ICSR (Individual Case Safety Report) construction, MedDRA coding, automated duplicate detection, regulatory transmission (ICH E2B), signal detection, and audit trails. This blog presents focused MCQs to strengthen conceptual and practical knowledge of each platform’s architecture, workflows, reporting capabilities, and compliance features. These questions are crafted to help students prepare for academic evaluations and real-world pharmacovigilance responsibilities.

Q1. Which statement best describes ICH E2B in the context of safety databases like Argus, ArisG, and VigiFlow?

• It is a MedDRA versioning protocol used only for coding adverse events
• It is the international XML standard for exchange of individual case safety reports (ICSRs)
• It is a proprietary database structure developed by Oracle for Argus
• It is an algorithm for signal detection implemented exclusively in VigiFlow

Correct Answer: It is the international XML standard for exchange of individual case safety reports (ICSRs)

Q2. Which feature is a primary advantage of Oracle Argus safety database in global pharmacovigilance operations?

• Built-in spontaneous reporting to WHO VigiBase without mapping
• Extensive configurable workflows, global compliance modules, and regulatory submissions
• Free, open-source access for academic institutions
• Exclusive use of ICD coding for adverse events

Correct Answer: Extensive configurable workflows, global compliance modules, and regulatory submissions

Q3. In pharmacovigilance databases, what is the primary purpose of MedDRA coding?

• To encrypt patient identifiers for privacy
• To standardize medical terms for adverse events, indications, and outcomes
• To calculate statistical signal scores automatically
• To generate batch release reports for manufacturing

Correct Answer: To standardize medical terms for adverse events, indications, and outcomes

Q4. VigiFlow is primarily maintained by which organization and designed to support what activity?

• EMA; for creating EU PSURs only
• WHO Uppsala Monitoring Centre; for national pharmacovigilance centres to manage ICSRs and report to VigiBase
• FDA; for pre-marketing clinical trial safety monitoring
• ICH; for harmonizing MedDRA dictionaries globally

Correct Answer: WHO Uppsala Monitoring Centre; for national pharmacovigilance centres to manage ICSRs and report to VigiBase

Q5. Which component is essential for regulatory case submission from Argus or ArisG to national authorities?

• MedDRA version number embedded in XML
• ICH E2B(R3) compliant XML with structured ICSR elements
• PDF-only CIOMS form without XML
• Manual email with Excel attachment of all fields

Correct Answer: ICH E2B(R3) compliant XML with structured ICSR elements

Q6. What is a typical function of duplicate detection modules in safety databases?

• Combine two different product records into one master product
• Identify ICSRs potentially reporting the same event to avoid double counting in signal detection
• Automatically delete older cases from the database
• Flag cases for immediate regulatory submission without review

Correct Answer: Identify ICSRs potentially reporting the same event to avoid double counting in signal detection

Q7. Which of the following best describes CIOMS forms in pharmacovigilance workflows?

• Standardized narrative templates used for clinical study protocols
• Internationally recognized case report forms for expedited and periodic safety reporting
• Drug manufacturing batch release certificates
• MedDRA maintenance release notes

Correct Answer: Internationally recognized case report forms for expedited and periodic safety reporting

Q8. When mapping data fields from a hospital source to ArisG or Argus, which principle is most important?

• Mapping must preserve semantics so source clinical terms map to correct MedDRA terms or ICSR fields
• Map all source fields to the ‘free text’ line to avoid errors
• Only map demographic fields; clinical information is not necessary
• Use local abbreviations instead of standard coding to maintain clinician familiarity

Correct Answer: Mapping must preserve semantics so source clinical terms map to correct MedDRA terms or ICSR fields

Q9. Which type of report is typically generated from Argus or ArisG for periodic aggregate safety assessment?

• Individual expedited ICSR only
• Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
• Only manufacturing deviation summary
• Clinical trial informed consent logs

Correct Answer: Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)

Q10. In a regulatory context, what does seriousness assessment in an ICSR determine?

• Whether the report is eligible for continuous monitoring by marketing department
• Whether the adverse event meets criteria (death, life-threatening, hospitalization, disability, congenital anomaly, other medically important) impacting expedited reporting timelines
• If the case should be anonymized before storage
• Whether the reporter is an HCP or non-HCP

Correct Answer: Whether the adverse event meets criteria (death, life-threatening, hospitalization, disability, congenital anomaly, other medically important) impacting expedited reporting timelines

Q11. Which audit feature is mandatory for pharmacovigilance databases to comply with good PV practice?

• Daily automatic deletion of older records
• Immutable audit trail capturing who changed what and when with timestamps
• Automatic assignment of causality to each case without reviewer input
• Integration with payroll systems for reviewer payments

Correct Answer: Immutable audit trail capturing who changed what and when with timestamps

Q12. Which analytical method is commonly used inside safety databases for initial signal detection?

• Disproportionality analysis (e.g., PRR, ROR, IC)
• Randomized controlled trial meta-analysis
• Standard deviation of batch release values
• Kaplan-Meier survival curves for all ICSRs

Correct Answer: Disproportionality analysis (e.g., PRR, ROR, IC)

Q13. When exporting an ICSR from Argus to a national authority, which metadata is essential to include?

• Source code of the database application
• Unique case identifiers, reporter type, seriousness, causality assessment, suspect drug(s), and event coding
• Employees’ personal contact numbers
• Raw uninterpreted audio files of the initial call only

Correct Answer: Unique case identifiers, reporter type, seriousness, causality assessment, suspect drug(s), and event coding

Q14. In VigiFlow implementations for a national centre, what is a common limitation compared to commercial systems like Argus?

• VigiFlow cannot report to WHO VigiBase
• VigiFlow is primarily tailored for national ICSR collection and may have fewer advanced enterprise integrations and customizable workflows than some commercial platforms
• VigiFlow lacks MedDRA support entirely
• VigiFlow automatically approves causality assessments without manual review

Correct Answer: VigiFlow is primarily tailored for national ICSR collection and may have fewer advanced enterprise integrations and customizable workflows than some commercial platforms

Q15. Which security control is critical when multiple affiliates access a centralized safety database?

• Single shared account for all users to simplify access
• Role-based access controls with segregation of duties and logging
• Disable all audit logs to improve performance
• Allow direct SQL access to all staff for faster reporting

Correct Answer: Role-based access controls with segregation of duties and logging

Q16. How do safety databases typically support follow-up information collection for an ICSR?

• By closing the case immediately after initial entry
• By providing follow-up status fields, scheduled tasks, and reminder workflows to capture updated outcomes and additional clinical details
• By exporting cases to Excel and requiring offline management only
• By deleting initial narratives and replacing them with summarized data

Correct Answer: By providing follow-up status fields, scheduled tasks, and reminder workflows to capture updated outcomes and additional clinical details

Q17. Which statement best explains the role of structured versus unstructured data in pharmacovigilance databases?

• Structured data (coded fields) enable regulatory exchange and analytics; unstructured data (narratives) provide clinical context that may require natural language processing or manual review
• Unstructured data are preferred for automatic regulatory submission
• Structured data are only used for storing attachments
• Narratives are redundant and should be deleted after coding

Correct Answer: Structured data (coded fields) enable regulatory exchange and analytics; unstructured data (narratives) provide clinical context that may require natural language processing or manual review

Q18. What is a common reason for performing data reconciliation between Argus/ArisG and local safety spreadsheets?

• To intentionally create duplicate records to test duplicate detection
• To ensure completeness and consistency of ICSRs, reconcile counts for regulatory deadlines, and verify transmitted reports
• To replace the database as the master with spreadsheets
• To validate employee credentials

Correct Answer: To ensure completeness and consistency of ICSRs, reconcile counts for regulatory deadlines, and verify transmitted reports

Q19. In the context of pharmacovigilance tools, what does ‘signal validation’ generally require beyond automated detection?

• Immediate public release of findings without review
• Clinical assessment, causality evaluation, review of case narratives, and consideration of background incidence and confounders
• Automatic deletion of supporting ICSRs
• Exclusive dependence on disproportionality score without expert input

Correct Answer: Clinical assessment, causality evaluation, review of case narratives, and consideration of background incidence and confounders

Q20. Which capability helps pharmacovigilance teams meet regulatory expedited reporting timelines within database systems?

• Manual paper filing only
• Automated case triage rules, alert notifications, and predefined regulatory transmission templates (e.g., E2B XML)
• Delaying case review until monthly meetings
• Batching all cases into a single annual report exclusively

Correct Answer: Automated case triage rules, alert notifications, and predefined regulatory transmission templates (e.g., E2B XML)

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