Medical Coding and Terminology Flashcards

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

Answer: MedDRA (Medical Dictionary for Regulatory Activities)

MedDRA is the internationally recognized coding dictionary used to classify adverse events, medical history, and other medical conditions in clinical trial data for regulatory submissions.

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

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

A Preferred Term is a distinct medical concept in MedDRA's hierarchy, sitting below High Level Terms and above Lowest Level Terms, and is the standard level for adverse event coding in submissions.

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

Answer: WHO Drug Dictionary (WHO-DD)

The WHO Drug Dictionary is the internationally recognized dictionary used to standardize the coding of concomitant medications, study drugs, and medical devices in clinical trial data.

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

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

The verbatim term is the original, unmodified text entered by the site on the CRF, which is then reviewed and mapped to the appropriate standard dictionary term during coding.

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

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

System Organ Class is the highest organizational level in MedDRA, grouping related medical concepts by body system, etiology, or purpose (e.g., Cardiac disorders, Infections and infestations).

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

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

A coding convention document provides rules and guidelines for consistently coding verbatim terms, reducing coder variability and ensuring comparable coding across sites and studies.