SCDM Database Design and Development 2

Question 1

What is the purpose of a 'database lock' in clinical data management?

Accepted Answer

To prevent further data changes after all queries are resolved and data is verified as clean

Answer

Database lock occurs after all data issues are resolved and the database is declared clean, preventing any further modifications before statistical analysis and reporting.

Question 2

Which CDISC standard is used to define CRF data collection fields and their mapping to database variables?

Accepted Answer

CDASH (Clinical Data Acquisition Standards Harmonization)

Answer

CDASH provides standardized field names and collection methodologies for CRFs, facilitating consistent data collection and easier mapping to SDTM submission datasets.

Question 3

What is the function of a 'back-end edit check' in a clinical EDC system?

Accepted Answer

A programmatic check run against the database to identify inconsistencies across records or visits

Answer

Back-end edit checks run programmatically against the database at defined intervals, identifying cross-form, cross-visit, or cross-subject inconsistencies that front-end checks may miss.

Question 4

In clinical database development, what is a 'test environment'?

Accepted Answer

A separate copy of the database used for validation testing without affecting production data

Answer

A test environment is an isolated replica of the production system used exclusively for validation, testing, and training without risking the integrity of live study data.

Question 5

What is 'data normalization' in the context of clinical trial database design?

Accepted Answer

Organizing data into tables to reduce redundancy and improve data integrity

Answer

Normalization organizes a relational database into well-defined tables and relationships to eliminate data redundancy, reduce anomalies, and improve overall data integrity.

SCDM - Society for Clinical Data Management Practice Test

SCDM - Society for Clinical Data Management Practice Test

SCDM Database Design and Development 2