CCRA Clinical Trial Monitoring Techniques 1

Question 1

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

Accepted Answer

To train site staff and confirm readiness to enroll subjects

Answer

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.

Question 2

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

Accepted Answer

Identified critical data and processes with the greatest patient risk potential

Answer

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.

Question 3

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

Accepted Answer

Original source documents such as medical records and lab reports

Answer

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.

Question 4

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

Accepted Answer

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

Answer

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.

Question 5

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

Accepted Answer

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

Answer

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.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Clinical Trial Monitoring Techniques 1