PVC Post-Marketing Surveillance 3

Question 1

Which of the following best defines a 'cohort event monitoring' study in post-marketing surveillance?

Accepted Answer

A prospective follow-up of a defined group of patients exposed to a specific drug to capture all medical events

Answer

Cohort event monitoring prospectively follows an exposed cohort, capturing all events regardless of suspected causality to identify safety signals.

Question 2

The Benefit-Risk Balance (BRB) assessment in post-marketing surveillance weighs which two primary factors?

Accepted Answer

Clinical benefits of treatment against known and potential risks

Answer

The BRB assessment compares the clinical benefits of a drug (efficacy, patient outcomes) to its risks (adverse effects, misuse potential) to justify continued marketing.

Question 3

In pharmacovigilance, a 'labeled' adverse event is one that:

Accepted Answer

Is already described in the product's current approved labeling

Answer

A labeled adverse event is one already listed in the approved product label; unlabeled (unexpected) events require expedited reporting.

Question 4

Which of the following signal detection methods compares the observed-to-expected ratio of drug-event combinations in spontaneous reporting databases?

Accepted Answer

Proportional Reporting Ratio (PRR)

Answer

The PRR is a disproportionality analysis method that compares how frequently a drug-event pair appears relative to all other drugs reporting that event.

Question 5

A pharmacovigilance professional receives an adverse event report where the patient outcome is listed as 'not recovered/not resolved.' How should the case be classified?

Accepted Answer

Serious, because ongoing harm qualifies as a serious outcome under ICH E2A

Answer

Under ICH E2A criteria, 'not recovered/not resolved' signifies persistent harm and must be considered when evaluating seriousness, which can qualify a case as serious.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Post-Marketing Surveillance 3