PVC Adverse Event Reporting & Case Management 2

Question 1

Which of the following best defines a 'serious adverse event' (SAE) under ICH E2A guidelines?

Accepted Answer

An event resulting in death, life-threatening situation, hospitalization, disability, or congenital anomaly

Answer

ICH E2A defines an SAE as one resulting in death, life-threatening risk, inpatient hospitalization, persistent disability, congenital anomaly, or a medically important event.

Question 2

A patient in a clinical trial experiences a hospitalization due to an elective cosmetic procedure. How should this be classified?

Accepted Answer

Non-serious adverse event, because elective procedures are excluded from SAE criteria

Answer

Elective hospitalizations that were pre-planned and not caused by the investigational product are excluded from SAE seriousness criteria.

Question 3

Under 21 CFR 312.32, what is the expedited reporting timeframe for an unexpected fatal or life-threatening SUSAR in a US IND?

Accepted Answer

7 calendar days for fatal/life-threatening, 15 calendar days for other unexpected serious events

Answer

FDA requires 7-calendar-day reports for fatal or life-threatening unexpected SUSARs and 15-calendar-day reports for other unexpected serious adverse drug reactions.

Question 4

What is the primary purpose of the MedWatch 3500A form in the US post-marketing pharmacovigilance system?

Accepted Answer

To submit mandatory expedited adverse event reports to FDA for marketed products

Answer

The MedWatch 3500A (mandatory reporting form) is used by manufacturers, importers, and distributors to submit required expedited safety reports to FDA for marketed products.

Question 5

In pharmacovigilance case processing, what does 'case narrative' refer to?

Accepted Answer

A concise medical summary of all relevant information in an individual case safety report

Answer

A case narrative is a concise, chronological medical summary that synthesizes all relevant information from an ICSR into a coherent clinical account.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Adverse Event Reporting & Case Management 2