CCDM Electronic Data Capture 3

Question 1

What is the primary purpose of a User Acceptance Testing (UAT) phase before an EDC system goes live?

Accepted Answer

To verify that the configured system meets all protocol requirements before use in the actual trial

Answer

UAT confirms that the EDC system's build correctly reflects the protocol requirements and performs as expected before actual subject data is entered.

Question 2

Under GDPR, which principle requires that personal data collected in an EDC system be limited to what is necessary for the specified purpose?

Accepted Answer

Data minimization

Answer

GDPR's data minimization principle mandates that only the minimum amount of personal data necessary for the trial's stated purpose be collected.

Question 3

Which of the following is a key advantage of EDC over paper-based data collection in multi-site clinical trials?

Accepted Answer

Provides real-time central monitoring of data completeness and quality

Answer

EDC enables sponsors and CROs to monitor data quality and completeness across all sites in real time, supporting risk-based monitoring strategies.

Question 4

When a data manager performs 'medical coding' within or alongside an EDC system, what is the primary tool used to code adverse events?

Accepted Answer

MedDRA (Medical Dictionary for Regulatory Activities)

Answer

MedDRA is the internationally recognized medical terminology dictionary used to code adverse events and medical history in clinical trial databases.

Question 5

A site coordinator changes a previously entered lab value and provides a reason for the change. In a compliant EDC system, the original value should be:

Accepted Answer

Retained in the audit trail alongside the corrected value and reason

Answer

21 CFR Part 11 and GCP require that original entries are never deleted; the audit trail must preserve the original value, the change, and the reason.

(CCDM) Certified Clinical Data Manager Practice Test

(CCDM) Certified Clinical Data Manager Practice Test

CCDM Electronic Data Capture 3