PVC Clinical Trials & Post-Marketing Surveillance 4

Question 1

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

Accepted Answer

Reporting Odds Ratio (ROR)

Answer

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

Question 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?

Accepted Answer

Randomized controlled trial with clinical endpoints

Answer

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

Question 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?

Accepted Answer

Promptly, and no later than the time of continuing review

Answer

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.

Question 4

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

Accepted Answer

Gaps in safety knowledge for specific populations not adequately studied

Answer

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.

Question 5

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

Accepted Answer

The disease severity that drives drug prescription also affects the outcome

Answer

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

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Clinical Trials & Post-Marketing Surveillance 4