SCDM Medical Coding and Terminology 1 — Questions and Answers
Question 1: Which coding dictionary is primarily used for coding adverse events in clinical trials?
- MedDRA (Medical Dictionary for Regulatory Activities) (Correct answer)
- ICD-10-CM
- SNOMED CT
- WHO Drug Dictionary
Correct 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.
Question 2: In MedDRA, what is a 'Preferred Term' (PT)?
- A distinct descriptor for a symptom, sign, disease, diagnosis, or therapeutic indication at a specific level of the hierarchy (Correct answer)
- The highest-level grouping of related medical concepts in MedDRA
- A synonym for a verbatim term entered by site staff
- The lowest-level code assigned to an individual patient's event
Correct 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.
Question 3: Which coding dictionary is used for coding medications and medical devices in clinical trial data?
- WHO Drug Dictionary (WHO-DD) (Correct answer)
- MedDRA
- ICD-11
- LOINC
Correct 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.
Question 4: What is 'verbatim term' in the context of medical coding?
- The exact term as recorded by the site on the CRF, before it is mapped to a standardized dictionary code (Correct answer)
- The official MedDRA term assigned to an adverse event
- The generic name of a drug as listed in WHO-DD
- A standardized synonym approved by the coding committee
Correct 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.
Question 5: What is a 'System Organ Class' (SOC) in MedDRA?
- The highest level in the MedDRA hierarchy, grouping Preferred Terms by anatomical, physiological, or etiological criteria (Correct answer)
- A classification of clinical trial endpoints by organ system
- A category of medications grouped by therapeutic area
- The lowest level in the MedDRA hierarchy for individual events
Correct 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).
Question 6: What is the purpose of a 'coding convention' document in clinical data management?
- To provide guidelines for how to consistently map verbatim terms to dictionary codes across the study (Correct answer)
- To define the statistical methodology for adverse event analysis
- To specify which adverse events must be reported to the FDA as SAEs
- To document the MedDRA version used in the regulatory submission
Correct 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.
SCDM Medical Coding and Terminology 1
Which coding dictionary is primarily used for coding adverse events in clinical trials?