PVC Medical Coding & MedDRA Terminology 1 — Questions and Answers
Question 1: What does MedDRA stand for?
- Medical Dictionary for Regulatory Activities (Correct answer)
- Medical Data Repository and Analysis
- Medication Documentation and Regulatory Assessment
- Medical Drug Reaction Abbreviation
Correct answer: Medical Dictionary for Regulatory Activities
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?
- Three
- Four
- Five (Correct answer)
- Six
Correct answer: Five
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?
- System Organ Class (SOC)
- High Level Term (HLT)
- Preferred Term (PT) (Correct answer)
- Lowest Level Term (LLT)
Correct answer: Preferred Term (PT)
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?
- High Level Group Term (HLGT)
- System Organ Class (SOC) (Correct answer)
- High Level Term (HLT)
- Preferred Term (PT)
Correct answer: System Organ Class (SOC)
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)?
- To capture verbatim reporter terms as synonyms or variants of a Preferred Term (Correct answer)
- To serve as the broadest classification category
- To represent laboratory findings exclusively
- To function as an intermediate level above the Preferred Term
Correct answer: To capture verbatim reporter terms as synonyms or variants of a Preferred Term
LLTs are synonyms, lexical variants, or abbreviations linked to a parent Preferred Term, designed to capture the exact language used by reporters.
Question 6: How frequently is MedDRA updated by the MSSO?
- Annually each January
- Twice a year, typically in March and September (Correct answer)
- Quarterly
- Every two years
Correct answer: Twice a year, typically in March and September
MedDRA is updated twice a year (semi-annually), typically releasing new versions in March and September, to incorporate new medical concepts and terminology.
Question 7: Which organization is responsible for maintaining and distributing MedDRA under ICH direction?
- FDA (Food and Drug Administration)
- EMA (European Medicines Agency)
- MSSO (Maintenance and Support Services Organization) (Correct answer)
- ICH Secretariat
Correct answer: MSSO (Maintenance and Support Services Organization)
The MSSO (Maintenance and Support Services Organization) is the designated body responsible for maintaining, distributing, and providing support for MedDRA on behalf of the ICH.
PVC Medical Coding & MedDRA Terminology 1
What does MedDRA stand for?