Data Standards & Database Design Flashcards

Which CDISC standard is specifically designed to represent clinical trial data for regulatory submission to the FDA and PMDA?

Answer: SDTM

SDTM (Study Data Tabulation Model) is the standard for organizing and formatting clinical study data for regulatory submissions.

In a relational database, what is the primary purpose of a foreign key constraint?

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.

What does the 'N' variable in SDTM domain datasets typically represent?

Answer: A numeric version of a character variable

In SDTM, variables ending in 'N' are numeric counterparts to character variables, enabling sorting and analysis.

Which normalization form eliminates transitive dependencies in a relational database?

Answer: Third Normal Form (3NF)

Third Normal Form (3NF) requires that all non-key attributes depend only on the primary key, eliminating transitive dependencies.

In CDASH, what is the primary design principle that distinguishes it from SDTM?

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.

A clinical database uses a code list table where each condition maps to a standardized term. This design pattern is best described as:

Answer: Controlled terminology mapping

Controlled terminology mapping links free-text or coded values to standardized dictionaries such as MedDRA or SNOMED CT.

Which SDTM special-purpose domain is used to capture the timing relationships between study events?

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.