PVC Medical Coding & MedDRA Terminology

Question 1

What does MedDRA stand for?

Accepted Answer

Medical Dictionary for Regulatory Activities

Answer

Medical Data Repository and Analysis

Answer

Medication Documentation and Regulatory Assessment

Answer

Medical Drug Reaction Abbreviation

Question 2

How many hierarchical levels does MedDRA contain?

Accepted Answer

Five

Answer

Three

Answer

Four

Answer

Six

Question 3

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

Accepted Answer

Preferred Term (PT)

Answer

System Organ Class (SOC)

Answer

High Level Term (HLT)

Answer

Lowest Level Term (LLT)

Question 4

What is the highest level in the MedDRA hierarchy?

Accepted Answer

System Organ Class (SOC)

Answer

High Level Group Term (HLGT)

Answer

High Level Term (HLT)

Answer

Preferred Term (PT)

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

To serve as the broadest classification category

Answer

To represent laboratory findings exclusively

Answer

To function as an intermediate level above the Preferred Term

Question 6

How frequently is MedDRA updated by the MSSO?

Accepted Answer

Twice a year, typically in March and September

Answer

Annually each January

Answer

Quarterly

Answer

Every two years

Question 7

Which organization is responsible for maintaining and distributing MedDRA under ICH direction?

Accepted Answer

MSSO (Maintenance and Support Services Organization)

Answer

FDA (Food and Drug Administration)

Answer

EMA (European Medicines Agency)

Answer

ICH Secretariat