PVC Medical Coding & MedDRA Terminology 3

Question 1

In E2B(R3) electronic adverse event reporting, which data format is used to transmit Individual Case Safety Reports (ICSRs)?

Accepted Answer

HL7 XML format

Answer

PDF documents

Answer

CSV spreadsheets

Answer

DOCX narrative format

Question 2

What does 'SMQ' stand for in the context of MedDRA?

Accepted Answer

Standardized MedDRA Query

Answer

Standard Medical Query

Answer

Safety Monitoring Query

Answer

Signal Management Query

Question 3

What is the primary purpose of Standardized MedDRA Queries (SMQs) in pharmacovigilance?

Accepted Answer

To provide validated search strategies for identifying cases of a defined medical condition

Answer

To replace narrative writing in case reports

Answer

To assign System Organ Classes to newly proposed medical terms

Answer

To translate verbatim reporter terms into Preferred Terms

Question 4

At which MedDRA level is data typically entered during verbatim coding, but NOT primarily used for regulatory submission analysis?

Accepted Answer

Lowest Level Term (LLT)

Answer

Preferred Term (PT)

Answer

High Level Term (HLT)

Answer

System Organ Class (SOC)

Question 5

What is the function of the High Level Group Term (HLGT) in the MedDRA hierarchy?

Accepted Answer

Grouping related High Level Terms (HLTs) for broader categorical analysis

Answer

Capturing verbatim terms from adverse event reports

Answer

Serving as the primary coding level for regulatory submissions

Answer

Defining which SOC is designated as primary for a PT

Question 6

Which of the following represents best practice in medical coding quality review?

Accepted Answer

Ensure the selected PT accurately and specifically reflects the clinical concept described

Answer

Always select the broadest available MedDRA Preferred Term to capture all possibilities

Answer

Default all events to the 'Investigations' SOC for consistency

Answer

Use LLTs for all regulatory submission analyses to maximize specificity

Question 7

What process is required in a pharmacovigilance safety database when transitioning to a new MedDRA version?

Accepted Answer

MedDRA recoding or version upgrade of existing terms

Answer

MedDRA migration to a new platform

Answer

MedDRA reconciliation with clinical trial data

Answer

MedDRA harmonization with WHO-ART