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

Preferred Term (PT)

Answer

High Level Term (HLT)

Answer

System Organ Class (SOC)

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

Coding a single case with multiple Preferred Terms

Answer

Using multiple LLTs to describe one clinical concept

Answer

Assigning multiple adverse events to a single case report

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

The SOC containing the greatest number of terms

Answer

The SOC representing cardiovascular disorders by convention

Answer

The SOC assigned by the local regulatory authority

Question 4

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

Accepted Answer

Gastrointestinal Disorders

Answer

Adverse Drug Reactions

Answer

Drug Safety Signals

Answer

Medication Interactions

Question 5

Which ICH guideline specifically covers MedDRA medical terminology implementation?

Accepted Answer

ICH M1

Answer

ICH E2A

Answer

ICH E2B

Answer

ICH E6

Question 6

When a verbatim adverse event term does not directly match any existing MedDRA LLT, what is the correct coding approach?

Accepted Answer

Select the most specific and clinically appropriate existing LLT

Answer

Submit a request to create a new MedDRA term before coding

Answer

Leave the coding field blank and document the limitation

Answer

Use only the SOC code as an approximation

Question 7

Approximately how many total terms does MedDRA contain in recent versions?

Accepted Answer

Approximately 80,000 terms

Answer

Approximately 5,000 terms

Answer

Approximately 15,000 terms

Answer

Approximately 500,000 terms