PVC Medical Coding & MedDRA Terminology 2 — Questions and Answers
Question 1: Which MedDRA term level is designed to best capture the reporter's original verbatim description of an adverse event?
- Preferred Term (PT)
- High Level Term (HLT)
- Lowest Level Term (LLT) (Correct answer)
- System Organ Class (SOC)
Correct answer: Lowest Level Term (LLT)
LLTs are specifically designed to capture verbatim reporter terminology and link it to the standardized Preferred Term used for analysis.
Question 2: What is meant by 'multi-axial' coding in MedDRA?
- Coding a single case with multiple Preferred Terms
- A single PT can be linked to more than one System Organ Class (Correct answer)
- Using multiple LLTs to describe one clinical concept
- Assigning multiple adverse events to a single case report
Correct answer: A single PT can be linked to more than one System Organ Class
Multi-axial coding means a single Preferred Term can be linked to more than one SOC, allowing retrieval under different organ system classifications depending on the analysis context.
Question 3: What is the 'primary SOC' designation in MedDRA?
- The SOC containing the greatest number of terms
- The SOC designated as the main classification for a specific Preferred Term (Correct answer)
- The SOC representing cardiovascular disorders by convention
- The SOC assigned by the local regulatory authority
Correct answer: The SOC designated as the main classification for a specific Preferred Term
When a PT is linked to multiple SOCs through multi-axial coding, one SOC is designated the primary SOC, indicating the most clinically relevant classification for that term.
Question 4: Which of the following is an actual MedDRA System Organ Class (SOC)?
- Gastrointestinal Disorders (Correct answer)
- Adverse Drug Reactions
- Drug Safety Signals
- Medication Interactions
Correct answer: Gastrointestinal Disorders
'Gastrointestinal Disorders' is a genuine MedDRA SOC; the other options are pharmacovigilance concepts, not MedDRA hierarchy terms.
Question 5: Which ICH guideline specifically covers MedDRA medical terminology implementation?
- ICH E2A
- ICH E2B
- ICH M1 (Correct answer)
- ICH E6
Correct answer: ICH M1
ICH M1 is the guideline dedicated to MedDRA terminology, providing guidance on its implementation and use in regulatory submissions worldwide.
Question 6: When a verbatim adverse event term does not directly match any existing MedDRA LLT, what is the correct coding approach?
- Submit a request to create a new MedDRA term before coding
- Select the most specific and clinically appropriate existing LLT (Correct answer)
- Leave the coding field blank and document the limitation
- Use only the SOC code as an approximation
Correct answer: Select the most specific and clinically appropriate existing LLT
When an exact match is unavailable, the coder must select the most specific, clinically appropriate existing LLT that best represents the verbatim report, as new terms cannot be created unilaterally.
Question 7: Approximately how many total terms does MedDRA contain in recent versions?
- Approximately 5,000 terms
- Approximately 15,000 terms
- Approximately 80,000 terms (Correct answer)
- Approximately 500,000 terms
Correct answer: Approximately 80,000 terms
MedDRA contains approximately 80,000 or more terms (predominantly LLTs) in recent versions, organized across its five-level hierarchy.
PVC Medical Coding & MedDRA Terminology 2
Which MedDRA term level is designed to best capture the reporter's original verbatim description of an adverse event?