Clinical Trial Monitoring Techniques Flashcards

What is the primary objective of a Site Initiation Visit (SIV)?

Answer: To train site staff and confirm readiness to enroll subjects

The SIV ensures that site staff are adequately trained on the protocol, procedures, and GCP requirements, and that all essential documents and supplies are in place before enrollment begins.

Risk-Based Monitoring (RBM) focuses monitoring resources primarily on:

Answer: Identified critical data and processes with the greatest patient risk potential

RBM, as endorsed by ICH E6(R2) and FDA guidance, prioritizes monitoring efforts based on identified risks to subject safety and data integrity rather than routine 100% source data verification.

Source Data Verification (SDV) involves comparing CRF data to:

Answer: Original source documents such as medical records and lab reports

SDV is the process of comparing data recorded in the CRF or EDC system against the original source documents to confirm accuracy, completeness, and consistency.

A Monitoring Visit Report (MVR) must be completed and submitted to the sponsor within the timeframe specified in the monitoring plan primarily to:

Answer: Document visit findings and ensure timely follow-up on issues identified

The MVR documents all findings, actions taken, and required follow-up items to ensure issues are tracked to resolution and the sponsor maintains oversight of site compliance.

During a monitoring visit, a CRA finds a discrepancy between the CRF and source data. The FIRST action should be:

Answer: Request a query be raised and ask site staff to correct the CRF with explanation

Discrepancies should be resolved through the formal query process so that any CRF corrections are made by authorized site staff with appropriate documentation and explanation.

What is the purpose of a Pre-Study Visit (PSV) or Site Qualification Visit (SQV)?

Answer: To assess the site's suitability, resources, and investigator qualifications before trial startup

The PSV/SQV evaluates whether the site has the required patient population, qualified personnel, facilities, and investigator commitment to conduct the trial successfully.