CCDM Data Standards & Database Design 4

Question 1

Which database design approach stores each attribute of an entity in a separate row rather than separate columns?

Accepted Answer

Entity-Attribute-Value (EAV) model

Answer

The Entity-Attribute-Value (EAV) model uses rows to represent attribute-value pairs, which is flexible for variable data structures but can complicate querying.

Question 2

When a clinical database undergoes a mid-study amendment to add a new data field, what is the MOST critical first step?

Accepted Answer

Assess impact on existing data, edit checks, and downstream derivations, then follow change control procedures

Answer

A formal impact assessment followed by change control procedures ensures that amendments are implemented without introducing inconsistencies or data integrity issues.

Question 3

In SDTM, what is the --TESTCD variable used for?

Accepted Answer

A code representing the type of test or measurement collected

Answer

--TESTCD is a short character code identifying the specific test or finding (e.g., 'SYSBP' for systolic blood pressure) within findings domains.

Question 4

What is the purpose of a 'data freeze' in clinical data management?

Accepted Answer

Locking the database at a defined point so no further changes can be made to data included in analysis

Answer

A data freeze locks the database at a specific point in time, ensuring that the dataset used for statistical analysis remains unchanged.

Question 5

Which of the following BEST describes a 'derived variable' in an ADaM dataset?

Accepted Answer

A variable calculated or transformed from collected or other derived data using documented, reproducible rules

Answer

Derived variables in ADaM are computed from raw or other derived data using pre-specified, documented algorithms to support analysis.

(CCDM) Certified Clinical Data Manager Practice Test

(CCDM) Certified Clinical Data Manager Practice Test

CCDM Data Standards & Database Design 4