Clinical Trial Monitoring Techniques Flashcards

Centralized monitoring differs from on-site monitoring in that it:

Answer: Involves remote review of accumulating data to identify trends and signals

Centralized monitoring uses statistical analysis and remote data review to detect data anomalies, enrollment patterns, and compliance signals without requiring a site visit.

Which of the following is an example of a critical process that should be prioritized during risk-based monitoring?

Answer: Informed consent process and documentation

The informed consent process is a critical process because failures directly affect subject rights and can invalidate subject participation from a regulatory standpoint.

A 'trigger' in risk-based monitoring refers to:

Answer: The signal that prompts an unplanned site visit or escalated review based on predefined thresholds

Triggers are predefined thresholds or signals (e.g., high query rate, low consent rate) that prompt escalated monitoring actions such as additional on-site or centralized review.

At a Site Closeout Visit (COV), which activity is MOST critical for the CRA to confirm?

Answer: All trial materials are accounted for and essential documents are complete and archived

During closeout, the CRA must ensure all investigational product is reconciled, essential documents are complete, and the site understands retention requirements for regulatory inspection readiness.

When performing source document verification, the CRA confirms that source data is ALCOA+. What does 'ALCOA' stand for?

Answer: Attributable, Legible, Contemporaneous, Original, Accurate

ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate — the five core data quality attributes required for clinical trial data.

A CRA identifies that a site coordinator has been backdating data entries in the EDC system. This should be classified as:

Answer: Data fraud requiring immediate escalation to the sponsor and possibly regulatory authorities

Backdating data is data fraud, which is a serious GCP violation requiring immediate escalation to the sponsor, and may necessitate reporting to regulatory authorities and potentially a for-cause audit.