When coding adverse events (AEs) usingMedDRA (Medical Dictionary for Regulatory Activities), valid AE terms must correspond to specific, medically meaningful concepts thatmatch directly to a Preferred Term (PT)orLowest Level Term (LLT)in the dictionary.
Among the options,“Elevated HDL”(High-Density Lipoprotein) represents a single, medically interpretable, and standard term that can directly match to a MedDRA LLT or PT. This makes it suitable forauto-coding, where the system automatically maps verbatim terms to MedDRA entries without manual intervention.
In contrast:
ALT (B)andAbnormal SGOT (C)are incomplete or nonspecific; they describe test names or qualitative interpretations rather than events.
Option Dlists multiple findings, making it too complex for automatic mapping. Such compound entries would requiremanual coding review.
According toGCDMP (Chapter: Medical Coding and Dictionaries), a valid AE term should be:
Clinically interpretable(not just a lab test name)
Unambiguous
Single-concept based, not a collection of results
Thus,option A (Elevated HDL)is correct, as it aligns with MedDRA’s single-concept, standard terminology structure suitable for auto-coding.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Medical Coding and Dictionaries, Section 5.3 – Auto-coding and Verbatim Term Management
ICH M1 MedDRA Term Selection: Points to Consider, Section 2.1 – Coding Principles
ICH E2B(R3) – Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
