SCDM Medical Coding and Terminology 2 — Questions and Answers
Question 1: What is 'autocoding' in clinical trial data management?
- The automatic mapping of verbatim terms to dictionary codes based on pre-approved synonym lists or prior coding decisions (Correct answer)
- The automatic generation of adverse event narratives from CRF data
- An AI system that replaces human medical coders entirely
- Automatic assignment of ICD codes by the EDC system
Correct 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.
Question 2: In MedDRA, which level sits directly below the Preferred Term (PT)?
- Lowest Level Term (LLT) (Correct answer)
- High Level Term (HLT)
- High Level Group Term (HLGT)
- System Organ Class (SOC)
Correct 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.
Question 3: What is 'upward coding' in the context of MedDRA adverse event reporting?
- The practice of selecting a higher-level, more inclusive Preferred Term than the specific verbatim term to group similar events (Correct answer)
- Updating verbatim terms to match newer MedDRA versions
- Coding events at the SOC level instead of the PT level
- Reclassifying events from serious to non-serious after review
Correct 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.
Question 4: What does LOINC stand for and what is its primary use in clinical trials?
- Logical Observation Identifiers Names and Codes — standardizes laboratory and clinical observation codes (Correct answer)
- Laboratory Outcome Identification and Nomenclature Criteria — codes adverse events
- Linked Online Identifier for New Compounds — codes investigational drugs
- Licensed Operational Index for Numerical Coding — codes vital signs
Correct 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.
Question 5: What is the purpose of a 'global coding team' in large multi-regional clinical trials?
- To provide centralized, consistent medical coding across all sites and regions using a single set of conventions (Correct answer)
- To translate CRF verbatim terms from multiple languages into English before coding
- To audit all site-level coding decisions before database lock
- To assign regional SOC classifications based on local medical terminology
Correct 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.
Question 6: What is 'dictionary versioning' in clinical data management?
- Tracking and documenting which version of MedDRA or WHO-DD was used to code data in a specific study (Correct answer)
- Updating all coded data when a new MedDRA version is released mid-study
- Maintaining multiple language versions of the coding dictionary
- Archiving previous dictionary versions after regulatory submission
Correct 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.
SCDM Medical Coding and Terminology 2
What is 'autocoding' in clinical trial data management?