CCDM Data Validation 2

Question 1

Which type of validation check ensures that a date field contains a value that is chronologically possible within the study context?

Accepted Answer

Logical check

Answer

A logical check verifies that dates are chronologically sensible, such as ensuring that the informed consent date precedes the first visit date.

Question 2

In clinical data management, what is a 'discrepancy' most accurately defined as?

Accepted Answer

A data value that does not meet predefined validation criteria

Answer

A discrepancy is a data value that fails to meet predefined validation criteria, triggering a query to the site for clarification or correction.

Question 3

What is the primary purpose of a User Acceptance Testing (UAT) phase in clinical database validation?

Accepted Answer

To confirm the database meets sponsor and regulatory requirements before go-live

Answer

UAT confirms that the clinical database system functions as specified and meets all sponsor and regulatory requirements before it is released for live data entry.

Question 4

Which edit check type would flag a record where a subject is noted as pregnant but the recorded gender is male?

Accepted Answer

Cross-field consistency check

Answer

A cross-field consistency check compares values across multiple fields to detect biologically or logically impossible combinations.

Question 5

According to ICH E6(R2), what should be the basis for the scope and nature of data validation procedures?

Accepted Answer

A risk-based approach focusing on critical data and processes

Answer

ICH E6(R2) mandates a risk-based approach to data management, meaning validation efforts should be proportionate to the risk and importance of the data.

(CCDM) Certified Clinical Data Manager Practice Test

(CCDM) Certified Clinical Data Manager Practice Test

CCDM Data Validation 2