PVC Clinical Trials & Post-Marketing Surveillance

Question 1

What is the primary goal of pharmacovigilance in clinical trials?

Accepted Answer

To monitor safety of investigational drugs

Answer

To analyze drug sales

Answer

To obtain regulatory approval faster

Answer

To promote new medicines

Question 2

Which phase of clinical trials focuses most on assessing a drug's safety profile?

Accepted Answer

Phase I

Answer

Phase II

Answer

Phase III

Answer

Phase IV

Question 3

Which report is essential for post-marketing safety surveillance?

Accepted Answer

Periodic Safety Update Report (PSUR)

Answer

Case Study Report

Answer

Site Monitoring Visit Report

Answer

Informed Consent Form

Question 4

Which regulatory document guides safety reporting during clinical trials?

Accepted Answer

ICH E2A

Answer

ICH E6

Answer

ICH Q10

Answer

ICH M4

Question 5

What is a key purpose of post-marketing surveillance?

Accepted Answer

To detect adverse events in real-world use

Answer

To conduct marketing campaigns

Answer

To replace clinical trials

Answer

To evaluate manufacturing cost

Question 6

Which of the following best describes a spontaneous report?

Accepted Answer

An unsolicited report of an adverse event

Answer

A formal report from a clinical trial

Answer

A mandatory report submitted by a sponsor

Answer

An internal audit document