SCDM Medical Coding and Terminology

Question 1

Which coding dictionary is primarily used for coding adverse events in clinical trials?

Accepted Answer

MedDRA (Medical Dictionary for Regulatory Activities)

Answer

ICD-10-CM

Answer

SNOMED CT

Answer

WHO Drug Dictionary

Question 2

In MedDRA, what is a 'Preferred Term' (PT)?

Accepted Answer

A distinct descriptor for a symptom, sign, disease, diagnosis, or therapeutic indication at a specific level of the hierarchy

Answer

The highest-level grouping of related medical concepts in MedDRA

Answer

A synonym for a verbatim term entered by site staff

Answer

The lowest-level code assigned to an individual patient's event

Question 3

Which coding dictionary is used for coding medications and medical devices in clinical trial data?

Accepted Answer

WHO Drug Dictionary (WHO-DD)

Answer

MedDRA

Answer

ICD-11

Answer

LOINC

Question 4

What is 'verbatim term' in the context of medical coding?

Accepted Answer

The exact term as recorded by the site on the CRF, before it is mapped to a standardized dictionary code

Answer

The official MedDRA term assigned to an adverse event

Answer

The generic name of a drug as listed in WHO-DD

Answer

A standardized synonym approved by the coding committee

Question 5

What is a 'System Organ Class' (SOC) in MedDRA?

Accepted Answer

The highest level in the MedDRA hierarchy, grouping Preferred Terms by anatomical, physiological, or etiological criteria

Answer

A classification of clinical trial endpoints by organ system

Answer

A category of medications grouped by therapeutic area

Answer

The lowest level in the MedDRA hierarchy for individual events

Question 6

What is the purpose of a 'coding convention' document in clinical data management?

Accepted Answer

To provide guidelines for how to consistently map verbatim terms to dictionary codes across the study

Answer

To define the statistical methodology for adverse event analysis

Answer

To specify which adverse events must be reported to the FDA as SAEs

Answer

To document the MedDRA version used in the regulatory submission