Medical Coding & MedDRA Terminology Flashcards

What does MedDRA stand for?

Answer: Medical Dictionary for Regulatory Activities

MedDRA stands for Medical Dictionary for Regulatory Activities, the standardized international medical terminology used in pharmacovigilance and regulatory submissions.

How many hierarchical levels does MedDRA contain?

Answer: Five

MedDRA contains five hierarchical levels: System Organ Class (SOC), High Level Group Term (HLGT), High Level Term (HLT), Preferred Term (PT), and Lowest Level Term (LLT).

Which MedDRA level serves as the primary coding level for adverse events in regulatory submissions?

Answer: Preferred Term (PT)

The Preferred Term (PT) is the primary level used for regulatory reporting and analysis, as it represents a single, distinct medical concept.

What is the highest level in the MedDRA hierarchy?

Answer: System Organ Class (SOC)

System Organ Class (SOC) is the highest level in MedDRA, organizing terms by broad groupings such as organ system, etiology, or manifestation site.

In MedDRA, what is the primary function of a Lowest Level Term (LLT)?

Answer: To capture verbatim reporter terms as synonyms or variants of a Preferred Term

LLTs are synonyms, lexical variants, or abbreviations linked to a parent Preferred Term, designed to capture the exact language used by reporters.

How frequently is MedDRA updated by the MSSO?

Answer: Twice a year, typically in March and September

MedDRA is updated twice a year (semi-annually), typically releasing new versions in March and September, to incorporate new medical concepts and terminology.

Which organization is responsible for maintaining and distributing MedDRA under ICH direction?

Answer: MSSO (Maintenance and Support Services Organization)

The MSSO (Maintenance and Support Services Organization) is the designated body responsible for maintaining, distributing, and providing support for MedDRA on behalf of the ICH.