CCDM Electronic Data Capture 2

Question 1

Which 21 CFR Part 11 requirement ensures that electronic records cannot be altered without detection?

Accepted Answer

Audit trails that capture all changes with timestamp and user identity

Answer

21 CFR Part 11 requires audit trails that record every change to electronic records, including who made the change and when.

Question 2

In an EDC system, what is the purpose of a 'data validation check' at the point of entry?

Accepted Answer

To flag out-of-range or logically inconsistent values immediately

Answer

Point-of-entry data validation checks catch errors in real time by flagging values that fall outside expected ranges or violate logical rules.

Question 3

A site enters a blood pressure reading of 450/200 mmHg. The EDC system generates an automatic query. This type of query is called a:

Accepted Answer

Programmatic or system-generated query

Answer

Programmatic or system-generated queries are automatically created by the EDC system when data violates pre-programmed edit checks.

Question 4

What does 'database lock' signify in the context of an EDC-managed clinical trial?

Accepted Answer

All data has been verified and the database is frozen for statistical analysis

Answer

Database lock means all data cleaning is complete, the database is verified, and it is frozen to prevent further changes before statistical analysis.

Question 5

Which user role in an EDC system is typically responsible for responding to data queries raised by the sponsor or CRO?

Accepted Answer

Site data entry operator or clinical research coordinator

Answer

The site's clinical research coordinator or data entry operator is responsible for reviewing and resolving queries on their entered data.

(CCDM) Certified Clinical Data Manager Practice Test