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

To restrict site access during a scheduled maintenance window

Answer

To archive old study data to an external server

Answer

To freeze database design before UAT begins

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

SDTM

Answer

ADaM

Answer

HL7 FHIR

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

A manual review of data by a data manager after site entry

Answer

A check performed by the site coordinator before form submission

Answer

A real-time alert sent to the monitor during site visits

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

The server hardware used to run the live production database

Answer

A staging area where subjects are randomized during UAT

Answer

A backup copy of the database stored off-site

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

Transforming raw data into standardized SDTM domains

Answer

Converting continuous variables into categorical ranges

Answer

Applying statistical transformations before analysis

Question 6

What is the significance of a 'change control' process in clinical database management?

Accepted Answer

It ensures all modifications to the database after go-live are documented, reviewed, and approved before implementation

Answer

It tracks changes to the informed consent form at study sites

Answer

It monitors real-time data entry rates across all sites

Answer

It controls who has access to the final locked dataset