Clinical Trial Monitoring Techniques Flashcards

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

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

RBM frameworks adjust visit frequency based on each site's individual risk indicators, including enrollment volume, protocol deviation history, and data quality metrics.

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:

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

All personnel performing trial-related duties must be listed on the Delegation of Authority Log; the PI must update it immediately to maintain GCP compliance before the sub-investigator continues trial activities.

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

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

A for-cause audit is triggered by specific concerns such as whistleblower reports, unusual data patterns, or serious GCP breaches, and is conducted to investigate the issue in depth.

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

Answer: Section 5 (Sponsor)

ICH E6(R2) Section 5 covers sponsor responsibilities, including establishing a monitoring system, selecting qualified monitors, and defining monitoring scope and frequency.

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

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

ICH E6(R2) section 5.18.2 states monitors must have scientific and/or clinical training and experience to evaluate the medical, pharmaceutical, and procedural aspects of a clinical trial.

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

Answer: A protocol deviation or violation

Enrolling a subject who fails to meet inclusion criteria is a protocol deviation (or violation if major), which must be documented, reported to the sponsor, and may require IRB notification.