Medical Coding and Terminology Flashcards

What is 'autocoding' in clinical trial data management?

Answer: The automatic mapping of verbatim terms to dictionary codes based on pre-approved synonym lists or prior coding decisions

Autocoding uses pre-approved synonym lists or prior approved coding decisions to automatically map matching verbatim terms to dictionary codes, reducing manual coding effort while maintaining accuracy.

In MedDRA, which level sits directly below the Preferred Term (PT)?

Answer: Lowest Level Term (LLT)

Lowest Level Terms (LLTs) sit directly below Preferred Terms in the MedDRA hierarchy and include synonyms, alternative spellings, and abbreviations that map up to a PT.

What is 'upward coding' in the context of MedDRA adverse event reporting?

Answer: The practice of selecting a higher-level, more inclusive Preferred Term than the specific verbatim term to group similar events

Upward coding selects a broader PT to encompass a range of related verbatim terms, though it should be used cautiously to avoid losing clinical specificity.

What does LOINC stand for and what is its primary use in clinical trials?

Answer: Logical Observation Identifiers Names and Codes — standardizes laboratory and clinical observation codes

LOINC provides universal codes for laboratory tests, clinical measurements, and observations, enabling consistent identification of lab results integrated into clinical trial databases.

What is the purpose of a 'global coding team' in large multi-regional clinical trials?

Answer: To provide centralized, consistent medical coding across all sites and regions using a single set of conventions

A global coding team centralizes medical coding to ensure consistent application of conventions, dictionary versions, and decision rules across all regions and sites in a multi-regional trial.

What is 'dictionary versioning' in clinical data management?

Answer: Tracking and documenting which version of MedDRA or WHO-DD was used to code data in a specific study

Dictionary versioning records which specific version of a coding dictionary (e.g., MedDRA v26.0) was used to code trial data, ensuring consistency and reproducibility of coding decisions.