SCDM Medical Coding and Terminology 1

Question 1

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

Accepted Answer

MedDRA (Medical Dictionary for Regulatory Activities)

Answer

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)?

Accepted Answer

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

Answer

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?

Accepted Answer

WHO Drug Dictionary (WHO-DD)

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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).

SCDM - Society for Clinical Data Management Practice Test

SCDM - Society for Clinical Data Management Practice Test

SCDM Medical Coding and Terminology 1