PVC Medical Coding & MedDRA Terminology 1

Question 1

What does MedDRA stand for?

Accepted Answer

Medical Dictionary for Regulatory Activities

Answer

MedDRA stands for Medical Dictionary for Regulatory Activities, the standardized international medical terminology used in pharmacovigilance and regulatory submissions.

Question 2

How many hierarchical levels does MedDRA contain?

Accepted Answer

Five

Answer

MedDRA contains five hierarchical levels: System Organ Class (SOC), High Level Group Term (HLGT), High Level Term (HLT), Preferred Term (PT), and Lowest Level Term (LLT).

Question 3

Which MedDRA level serves as the primary coding level for adverse events in regulatory submissions?

Accepted Answer

Preferred Term (PT)

Answer

The Preferred Term (PT) is the primary level used for regulatory reporting and analysis, as it represents a single, distinct medical concept.

Question 4

What is the highest level in the MedDRA hierarchy?

Accepted Answer

System Organ Class (SOC)

Answer

System Organ Class (SOC) is the highest level in MedDRA, organizing terms by broad groupings such as organ system, etiology, or manifestation site.

Question 5

In MedDRA, what is the primary function of a Lowest Level Term (LLT)?

Accepted Answer

To capture verbatim reporter terms as synonyms or variants of a Preferred Term

Answer

LLTs are synonyms, lexical variants, or abbreviations linked to a parent Preferred Term, designed to capture the exact language used by reporters.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Medical Coding & MedDRA Terminology 1