Medical Coding and Terminology Flashcards

What is a 'coding query' in clinical trial data management?

Answer: A request to site staff for clarification on a verbatim term when the appropriate dictionary code cannot be determined

A coding query is sent to the site when a verbatim term is ambiguous or insufficient to determine the correct dictionary code, requesting additional clinical context or clarification.

Which organization maintains and updates the MedDRA dictionary?

Answer: The ICH MedDRA Management Committee (MSSO)

MedDRA is maintained by the ICH MedDRA Maintenance and Support Services Organization (MSSO), which releases two new versions per year incorporating new terms and hierarchy changes.

What is a 'recoding exercise' in clinical data management?

Answer: Revisiting and updating coded terms when a new version of a coding dictionary is adopted mid-study

A recoding exercise involves reviewing and updating coded terms to align with a new dictionary version, requiring careful documentation and impact assessment for regulatory submission consistency.

In clinical coding, what is a 'synonym list'?

Answer: A pre-approved list mapping specific verbatim terms to their corresponding dictionary codes to enable autocoding

A synonym list is a validated reference that maps common verbatim terms to approved dictionary codes, enabling autocoding and reducing the need for manual coder review of repetitive terms.

What is the primary difference between MedDRA PTs 'fatigue' and 'asthenia'?

Answer: They are separate, distinct Preferred Terms that should be coded based on the clinical context described in the verbatim term

Fatigue and asthenia are two distinct MedDRA Preferred Terms under the same SOC; fatigue refers to tiredness while asthenia refers to weakness, requiring selection based on clinical context.

What is the role of a 'medical coder' in clinical data management?

Answer: To review verbatim terms from CRFs and map them to the appropriate standard dictionary codes using medical knowledge and coding conventions

A medical coder applies medical knowledge and study-specific conventions to accurately assign standard dictionary codes (MedDRA, WHO-DD) to verbatim terms recorded in CRFs.