PVC Medical Coding & MedDRA Terminology 2

Question 1

Which MedDRA term level is designed to best capture the reporter's original verbatim description of an adverse event?

Accepted Answer

Lowest Level Term (LLT)

Answer

LLTs are specifically designed to capture verbatim reporter terminology and link it to the standardized Preferred Term used for analysis.

Question 2

What is meant by 'multi-axial' coding in MedDRA?

Accepted Answer

A single PT can be linked to more than one System Organ Class

Answer

Multi-axial coding means a single Preferred Term can be linked to more than one SOC, allowing retrieval under different organ system classifications depending on the analysis context.

Question 3

What is the 'primary SOC' designation in MedDRA?

Accepted Answer

The SOC designated as the main classification for a specific Preferred Term

Answer

When a PT is linked to multiple SOCs through multi-axial coding, one SOC is designated the primary SOC, indicating the most clinically relevant classification for that term.

Question 4

Which of the following is an actual MedDRA System Organ Class (SOC)?

Accepted Answer

Gastrointestinal Disorders

Answer

'Gastrointestinal Disorders' is a genuine MedDRA SOC; the other options are pharmacovigilance concepts, not MedDRA hierarchy terms.

Question 5

Which ICH guideline specifically covers MedDRA medical terminology implementation?

Accepted Answer

ICH M1

Answer

ICH M1 is the guideline dedicated to MedDRA terminology, providing guidance on its implementation and use in regulatory submissions worldwide.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Medical Coding & MedDRA Terminology 2