Practice Test Geeks(PVC) Pharmacovigilance Certification Practice Test
← All PVC Flashcard Decks

Clinical Trials & Post-Marketing Surveillance 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 Clinical Trials & Post-Marketing Surveillance flashcards as text

  1. Which metric in a disproportionality analysis indicates a statistically significant drug-event association when its lower 95% confidence interval exceeds 1.0?

    Answer: Reporting Odds Ratio (ROR)

    An ROR with a lower 95% CI above 1.0 (or IC025 > 0 for IC methods) indicates a statistically significant disproportionate reporting association.

  2. A post-marketing surveillance program detects a potential interaction between a proton pump inhibitor and a new antiplatelet agent. Which study design would provide the STRONGEST evidence for causality?

    Answer: Randomized controlled trial with clinical endpoints

    A randomized controlled trial provides the highest level of evidence for establishing causality by controlling for confounding and allocation bias.

  3. In a clinical trial, the term 'protocol deviation' that could affect subject safety or data integrity must be reported to the IRB within what timeframe under FDA regulations?

    Answer: Promptly, and no later than the time of continuing review

    FDA regulations require prompt reporting of protocol deviations that may affect subject rights, safety, or welfare, generally at the time of continuing review or sooner.

  4. The EU Risk Management Plan (RMP) contains a 'missing information' section. What does this section describe?

    Answer: Gaps in safety knowledge for specific populations not adequately studied

    The 'missing information' section of an EU RMP identifies populations such as pregnant women, pediatric patients, or those with renal impairment where safety data is limited.

  5. During a post-marketing study, confounding by indication is a major concern. What does this term mean?

    Answer: The disease severity that drives drug prescription also affects the outcome

    Confounding by indication occurs when the underlying disease for which a drug is prescribed is itself a risk factor for the outcome under study.

  6. Under ICH E2B(R3), what is the standard format for electronic transmission of individual case safety reports (ICSRs)?

    Answer: XML-based E2B(R3) message

    ICH E2B(R3) specifies an XML-based message format for electronic ICSR transmission between stakeholders and regulatory authorities.

  7. A sponsor's pharmacovigilance system must include a Qualified Person Responsible for Pharmacovigilance (QPPV) under which regulatory framework?

    Answer: EU Directive 2001/83/EC and Regulation (EU) No 726/2004

    EU legislation mandates that marketing authorization holders appoint a QPPV who has overall responsibility for the pharmacovigilance system in the EU.