Medical Coding & MedDRA Terminology Flashcards
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Which MedDRA term level is designed to best capture the reporter's original verbatim description of an adverse event?
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.
What is meant by 'multi-axial' coding in MedDRA?
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.
What is the 'primary SOC' designation in MedDRA?
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.
Which of the following is an actual MedDRA System Organ Class (SOC)?
Answer: Gastrointestinal Disorders
'Gastrointestinal Disorders' is a genuine MedDRA SOC; the other options are pharmacovigilance concepts, not MedDRA hierarchy terms.
Which ICH guideline specifically covers MedDRA medical terminology implementation?
Answer: ICH M1
ICH M1 is the guideline dedicated to MedDRA terminology, providing guidance on its implementation and use in regulatory submissions worldwide.
When a verbatim adverse event term does not directly match any existing MedDRA LLT, what is the correct coding approach?
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.
Approximately how many total terms does MedDRA contain in recent versions?
Answer: Approximately 80,000 terms
MedDRA contains approximately 80,000 or more terms (predominantly LLTs) in recent versions, organized across its five-level hierarchy.