CCDM Database Management 4

Question 1

In CDISC standards, what does the SDTM model primarily define?

Accepted Answer

The format for submitting clinical trial data to regulatory agencies

Answer

The Study Data Tabulation Model (SDTM) defines a standard structure for organizing and formatting clinical study data for submission to regulatory agencies like the FDA.

Question 2

What is a primary key in a clinical trial database table?

Accepted Answer

A unique identifier for each record within a table

Answer

A primary key is a unique identifier assigned to each record in a database table, ensuring no two records have the same key value.

Question 3

Which of the following best describes a 'flat file' in the context of clinical data exchange?

Accepted Answer

A simple text-based file where data is organized in rows and columns without relational structure

Answer

A flat file is a simple text-based file (such as CSV or TXT) that stores data in a two-dimensional format without the relational structure of a database.

Question 4

When a clinical database undergoes a significant amendment mid-study, what is required before implementation?

Accepted Answer

Revalidation and documentation of the changes according to change control procedures

Answer

Any significant changes to a validated clinical database must follow formal change control procedures, including documentation, impact assessment, revalidation, and approval before implementation.

Question 5

What is a 'derived variable' in clinical database management?

Accepted Answer

A variable whose value is computed from other collected data rather than directly entered

Answer

A derived variable is calculated from other variables in the database (e.g., BMI derived from height and weight) rather than being directly entered by site staff.

(CCDM) Certified Clinical Data Manager Practice Test

(CCDM) Certified Clinical Data Manager Practice Test

CCDM Database Management 4