CCDM Data Standards & Database Design 2

Question 1

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

Accepted Answer

SDTM

Answer

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?

Accepted Answer

Enforce referential integrity between tables

Answer

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?

Accepted Answer

A numeric version of a character variable

Answer

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?

Accepted Answer

Third Normal Form (3NF)

Answer

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?

Accepted Answer

CDASH is designed for data collection at the point of entry

Answer

CDASH (Clinical Data Acquisition Standards Harmonization) defines standards for collecting data on case report forms, not for submission formatting.

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