PVC Clinical Trials & Post-Marketing Surveillance 2

Question 1

Which regulatory framework requires sponsors to submit Individual Case Safety Reports (ICSRs) for serious unexpected adverse events during clinical trials?

Accepted Answer

ICH E2A Clinical Safety Data Management

Answer

ICH E2A defines expedited reporting requirements for serious unexpected adverse drug reactions occurring during clinical development.

Question 2

A Phase II oncology trial observes a cluster of Grade 3 hepatotoxicity events. What is the FIRST action the Data Safety Monitoring Board (DSMB) should take?

Accepted Answer

Conduct an unblinded review of the safety data

Answer

The DSMB's primary role is to review unblinded safety data to determine whether the observed events warrant trial modification or termination.

Question 3

In post-marketing surveillance, a Periodic Safety Update Report (PSUR) is submitted at what frequency for a newly approved drug in its first two years?

Accepted Answer

Every 6 months

Answer

ICH E2C(R2) requires PSURs every 6 months for the first 2 years post-approval to enable close monitoring of new medicines.

Question 4

Which type of post-marketing study is specifically mandated by regulators to fulfill a condition of approval and must be completed within an agreed timeframe?

Accepted Answer

Post-Authorization Safety Study (PASS)

Answer

A PASS is a regulatory commitment study designed to evaluate safety concerns identified at the time of approval.

Question 5

A marketed drug's spontaneous reporting rate for agranulocytosis suddenly doubles over three months. Under the FDA sentinel system, what is the most appropriate next step?

Accepted Answer

Conduct a disproportionality analysis using ROR or PRR

Answer

Disproportionality analysis using Reporting Odds Ratio (ROR) or Proportional Reporting Ratio (PRR) is the standard signal detection method for spontaneous report databases.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Clinical Trials & Post-Marketing Surveillance 2