CCRA Clinical Trial Monitoring Techniques

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

To collect final data and close the site

Answer

To resolve outstanding data queries

Answer

To audit financial records

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

Sites with the highest enrollment numbers

Answer

Regulatory submission timelines

Answer

Sites closest geographically to the sponsor

Question 3

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

Accepted Answer

Original source documents such as medical records and lab reports

Answer

The protocol

Answer

The investigator brochure

Answer

The monitoring report

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

Bill the site for monitoring costs

Answer

Satisfy enrollment quotas

Answer

Archive IRB correspondence

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

Correct the CRF entry directly

Answer

Remove the subject from the dataset

Answer

Immediately report to the FDA

Question 6

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

Accepted Answer

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

Answer

To conduct final data lock activities

Answer

To re-consent subjects following a protocol amendment

Answer

To perform a closeout audit