CCDM Data Standards & Database Design 5

Question 1

Which CDISC standard provides the framework for electronic data capture (EDC) systems using XML-based data exchange?

Accepted Answer

ODM (Operational Data Model)

Answer

The CDISC Operational Data Model (ODM) is an XML-based standard for exchanging and archiving clinical and translational research data across EDC systems.

Question 2

When designing a clinical database, what is the primary reason to separate 'visit date' from 'assessment date' as distinct fields?

Accepted Answer

Because assessments may occur outside of scheduled visits, and recording both dates maintains accuracy

Answer

Assessments may occur on different dates than the visit (e.g., lab samples sent to a central lab), so capturing both dates maintains accurate temporal records.

Question 3

What is the significance of the STUDYID variable being consistent across all SDTM domains in a submission?

Accepted Answer

It links all datasets to the same study and enables cross-domain data integration

Answer

A consistent STUDYID across all domains ensures that data from different domains can be reliably linked and integrated during regulatory review.

Question 4

A database designer chooses to use surrogate keys instead of natural keys as primary identifiers. What is the MAIN benefit of this approach in clinical data management?

Accepted Answer

Surrogate keys are system-generated, immune to changes in natural data attributes, and prevent integrity issues when source identifiers change

Answer

Surrogate keys are stable, system-generated identifiers that remain unchanged even if natural identifiers (like subject IDs) are corrected or reassigned.

Question 5

In SDTM, the --ORRES variable stores the original result as collected. What is the purpose of the corresponding --STRESC variable?

Accepted Answer

To hold the standardized result in character format, allowing consistent representation for both numeric and text results

Answer

--STRESC stores the original result converted to a standard character format, facilitating consistent interpretation across mixed numeric and text result types.

(CCDM) Certified Clinical Data Manager Practice Test

(CCDM) Certified Clinical Data Manager Practice Test

CCDM Data Standards & Database Design 5