PVC Clinical Trials & Post-Marketing Surveillance 1

Question 1

What is the primary goal of pharmacovigilance in clinical trials?

Accepted Answer

To monitor safety of investigational drugs

Answer

During clinical trials, pharmacovigilance aims to ensure the early detection of safety signals and protect trial participants.

Question 2

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

Accepted Answer

Phase I

Answer

Phase I trials are designed to assess the safety, tolerability, and pharmacokinetics of a drug in healthy volunteers or patients.

Question 3

Which report is essential for post-marketing safety surveillance?

Accepted Answer

Periodic Safety Update Report (PSUR)

Answer

Periodic Safety Update Reports (PSURs) are submitted after a drug is approved to monitor its benefit-risk profile in the general population.

Question 4

Which regulatory document guides safety reporting during clinical trials?

Accepted Answer

ICH E2A

Answer

ICH E2A provides guidance for clinical safety data management, particularly the reporting of adverse drug reactions in trials.

Question 5

What is a key purpose of post-marketing surveillance?

Accepted Answer

To detect adverse events in real-world use

Answer

Post-marketing surveillance ensures ongoing monitoring of drug safety and helps detect rare or long-term adverse effects not found in trials.

(PVC) Pharmacovigilance Certification Practice Test