PVC Adverse Event Reporting & Case Management

Question 1

Which of the following is considered a serious adverse event (SAE)?

Accepted Answer

Hospitalization due to severe allergic reaction

Answer

Mild headache lasting a few hours

Answer

Injection site pain

Answer

Temporary rash with no treatment

Question 2

What is the minimum required information to consider a valid Individual Case Safety Report (ICSR)?

Accepted Answer

Four minimum criteria: reporter, patient, event, drug

Answer

Only the patient’s full medical history

Answer

A suspected drug and a lab test result

Answer

Just a description of the adverse event

Question 3

Which coding system is primarily used to classify adverse events in pharmacovigilance?

Accepted Answer

MedDRA

Answer

ICD-10

Answer

SNOMED

Answer

LOINC

Question 4

Who is responsible for reporting adverse events in post-marketing surveillance?

Accepted Answer

Healthcare providers, patients, and manufacturers

Answer

Only the manufacturer

Answer

Only healthcare providers

Answer

Only patients

Question 5

What is the appropriate timeline for reporting a fatal adverse drug reaction to regulatory authorities?

Accepted Answer

7 calendar days

Answer

15 calendar days

Answer

21 working days

Answer

30 calendar days

Question 6

In a clinical trial setting, who is typically responsible for initial adverse event reporting?

Accepted Answer

Trial investigator

Answer

The FDA

Answer

Clinical trial sponsor

Answer

The patient