Signal Detection & Analysis Flashcards
7 cards from real PVC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Signal Detection & Analysis flashcards as text
What is 'signal closure' in the pharmacovigilance signal management lifecycle?
Answer: The formal conclusion of signal evaluation with documented rationale, including any label updates or risk minimization actions taken
Signal closure documents the outcome of the full evaluation cycle, including whether the signal was confirmed, refuted, or requires ongoing monitoring, and what actions were taken.
In Empirical Bayes signal detection, why are drug-event pairs with very high observed counts less affected by Bayesian shrinkage?
Answer: Large observed counts provide sufficient statistical evidence, so the posterior estimate closely approaches the observed disproportionality without needing correction toward the prior
With abundant data, the likelihood dominates the prior in Bayesian analysis, so the posterior EBGM converges toward the observed ROR with minimal shrinkage.
Which of the following represents a 'hypothesis-strengthening' activity performed during the signal evaluation phase?
Answer: Literature review for published case reports, mechanistic studies, and animal data supporting the association
Literature review identifies external evidence including mechanistic plausibility, animal toxicology, and published case series that corroborate or refute the detected signal.
When comparing ROR and PRR for signal detection in large databases, under what condition do the two measures yield virtually identical results?
Answer: When the adverse event of interest is rare relative to all reports in the database
ROR and PRR converge mathematically when the adverse event is rare because the denominator terms in each formula become approximately equal under low event prevalence.
A MAH detects a new signal for QT prolongation with their antifungal product. Which additional dataset would be MOST valuable for quantifying the absolute risk magnitude?
Answer: A comparative cohort study using electronic health records with ECG data and drug exposure records
An electronic health record cohort study can estimate incidence rates in exposed vs. unexposed patients with ECG confirmation, providing absolute and relative risk measures unavailable from spontaneous data.
The concept of 'signal consolidation' in pharmacovigilance refers to:
Answer: Grouping related drug-event pairs (e.g., across MedDRA PT siblings within an SMQ) to evaluate a broader safety topic coherently
Signal consolidation groups related preferred terms—often using Standardized MedDRA Queries (SMQs)—to capture the full spectrum of a clinical syndrome rather than evaluating isolated PTs.
Under EU GVP Module IX, what is the minimum expected frequency for signal detection activities for centrally authorized products by the Marketing Authorization Holder?
Answer: Continuously for signals from EudraVigilance, with formal review at least monthly
GVP Module IX requires MAHs to monitor EudraVigilance data continuously and conduct formal signal detection reviews at least on a monthly basis for CAPs.