CCRA Clinical Trial Monitoring Techniques 3

Question 1

The 'monitoring visit frequency' for a given site in a risk-based approach is primarily determined by:

Accepted Answer

The site's risk profile, enrollment rate, and compliance history

Answer

The CRA's personal schedule

Answer

The distance from the sponsor's office

Answer

Protocol phase (I, II, III, or IV)

Question 2

During a monitoring visit, a CRA notices the Delegation of Authority Log does not include a recently added sub-investigator. The BEST action is to:

Accepted Answer

Require the PI to update the log before the sub-investigator performs any further trial-related activities

Answer

Perform the visit as planned and note it as a non-issue

Answer

Remove the sub-investigator from all future trial activities

Answer

Submit a protocol deviation on behalf of the site

Question 3

What is a 'For-Cause Audit' in clinical research?

Accepted Answer

An unplanned audit triggered by signals of potential fraud, GCP violations, or data integrity concerns

Answer

A scheduled routine audit performed annually

Answer

An audit performed solely for financial compliance

Answer

A required pre-submission audit before NDA filing

Question 4

Which ICH-GCP section outlines the sponsor's responsibilities regarding monitoring?

Accepted Answer

Section 5 (Sponsor)

Answer

Section 4 (Investigator)

Answer

Section 6 (Protocol)

Answer

Section 8 (Essential Documents)

Question 5

A CRA should have which qualification as a minimum to independently monitor clinical trials per ICH-GCP?

Accepted Answer

Scientific or clinical training and experience enabling proper assessment of medical, pharmaceutical, and data aspects of the trial

Answer

A PhD in pharmacology

Answer

A law degree specializing in FDA regulations

Answer

10 years of nursing experience

Question 6

When a CRA finds that a site has enrolled a subject who did not meet all inclusion criteria, this is documented as:

Accepted Answer

A protocol deviation or violation

Answer

An adverse event

Answer

A serious breach of confidentiality

Answer

An investigational product discrepancy