Data Standards & Database Design Flashcards
7 cards from real CCDM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Data Standards & Database Design flashcards as text
Which database design approach stores each attribute of an entity in a separate row rather than separate columns?
Answer: Entity-Attribute-Value (EAV) model
The Entity-Attribute-Value (EAV) model uses rows to represent attribute-value pairs, which is flexible for variable data structures but can complicate querying.
When a clinical database undergoes a mid-study amendment to add a new data field, what is the MOST critical first step?
Answer: Assess impact on existing data, edit checks, and downstream derivations, then follow change control procedures
A formal impact assessment followed by change control procedures ensures that amendments are implemented without introducing inconsistencies or data integrity issues.
In SDTM, what is the --TESTCD variable used for?
Answer: A code representing the type of test or measurement collected
--TESTCD is a short character code identifying the specific test or finding (e.g., 'SYSBP' for systolic blood pressure) within findings domains.
What is the purpose of a 'data freeze' in clinical data management?
Answer: Locking the database at a defined point so no further changes can be made to data included in analysis
A data freeze locks the database at a specific point in time, ensuring that the dataset used for statistical analysis remains unchanged.
Which of the following BEST describes a 'derived variable' in an ADaM dataset?
Answer: A variable calculated or transformed from collected or other derived data using documented, reproducible rules
Derived variables in ADaM are computed from raw or other derived data using pre-specified, documented algorithms to support analysis.
A sponsor uses WHODRUG for coding study medications. What does WHODRUG primarily provide?
Answer: A global drug dictionary for identifying and coding medicinal products
WHODRUG is a global drug dictionary maintained by the Uppsala Monitoring Centre, used to code and standardize concomitant and prior medication data.
In the context of database validation, what is a 'data completeness check'?
Answer: Verifying that all expected records and required fields are present and populated
A data completeness check verifies that all required data points specified in the protocol are present in the database with no unexpected missing values.