CCDM Data Standards & Database Design 2 — Questions and Answers
Question 1: Which CDISC standard is specifically designed to represent clinical trial data for regulatory submission to the FDA and PMDA?
- CDASH
- SDTM (Correct answer)
- ADaM
- SEND
Correct answer: SDTM
SDTM (Study Data Tabulation Model) is the standard for organizing and formatting clinical study data for regulatory submissions.
Question 2: In a relational database, what is the primary purpose of a foreign key constraint?
- Uniquely identify each row in a table
- Enforce referential integrity between tables (Correct answer)
- Speed up query performance on indexed columns
- Prevent NULL values in critical fields
Correct answer: Enforce referential integrity between tables
A foreign key constraint enforces referential integrity by ensuring that a value in one table corresponds to a valid value in a related table.
Question 3: What does the 'N' variable in SDTM domain datasets typically represent?
- A numeric version of a character variable (Correct answer)
- The number of subjects in a group
- A flag indicating normal range
- The sequence number within a domain
Correct answer: A numeric version of a character variable
In SDTM, variables ending in 'N' are numeric counterparts to character variables, enabling sorting and analysis.
Question 4: Which normalization form eliminates transitive dependencies in a relational database?
- First Normal Form (1NF)
- Second Normal Form (2NF)
- Third Normal Form (3NF) (Correct answer)
- Boyce-Codd Normal Form (BCNF)
Correct answer: Third Normal Form (3NF)
Third Normal Form (3NF) requires that all non-key attributes depend only on the primary key, eliminating transitive dependencies.
Question 5: In CDASH, what is the primary design principle that distinguishes it from SDTM?
- CDASH focuses on analysis-ready datasets
- CDASH is designed for data collection at the point of entry (Correct answer)
- CDASH applies only to laboratory data domains
- CDASH replaces SDTM for FDA submissions
Correct answer: CDASH is designed for data collection at the point of entry
CDASH (Clinical Data Acquisition Standards Harmonization) defines standards for collecting data on case report forms, not for submission formatting.
Question 6: A clinical database uses a code list table where each condition maps to a standardized term. This design pattern is best described as:
- Denormalization
- Controlled terminology mapping (Correct answer)
- Entity-attribute-value modeling
- Surrogate key implementation
Correct answer: Controlled terminology mapping
Controlled terminology mapping links free-text or coded values to standardized dictionaries such as MedDRA or SNOMED CT.
Question 7: Which SDTM special-purpose domain is used to capture the timing relationships between study events?
- DM (Demographics)
- SE (Subject Elements) (Correct answer)
- TV (Trial Visits)
- TS (Trial Summary)
Correct answer: SE (Subject Elements)
The SE (Subject Elements) domain records the actual start and end dates of each period or element a subject experienced during the trial.
CCDM Data Standards & Database Design 2
Which CDISC standard is specifically designed to represent clinical trial data for regulatory submission to the FDA and PMDA?