CCDM Risk-Based Monitoring 5

Question 1

Which of the following is an example of a critical-to-quality factor that RBM would prioritize?

Accepted Answer

Accurate assessment of the primary endpoint

Answer

Critical-to-quality factors are those essential to subject protection and reliability of the primary results, such as primary endpoint assessment.

Question 2

A site has a very low adverse event reporting rate compared with similar sites. What is the most plausible risk this KRI highlights?

Accepted Answer

Under-reporting of adverse events

Answer

A rate far below peers can indicate under-reporting, a patient safety and data integrity risk.

Question 3

What is the main role of the data manager in a remote or centralized monitoring model?

Accepted Answer

Provide timely, clean, integrated data and reports that enable risk signal detection

Answer

Data management supplies the integrated, timely data and listings that central monitors depend on.

Question 4

Which document should describe KRI thresholds, review frequency and escalation actions in an RBM study?

Accepted Answer

Monitoring plan or risk management plan

Answer

The monitoring plan or risk management plan documents the KRIs, thresholds, cadence and escalation steps.

Question 5

Targeted SDV differs from traditional 100% SDV mainly because it:

Accepted Answer

Focuses verification on critical data and higher-risk sites or subjects

Answer

Targeted SDV concentrates verification effort on critical data points and areas of elevated risk.

(CCDM) Certified Clinical Data Manager Practice Test