CCRA Site Initiation, Qualification, and Close-Out Procedures

Question 1

What is the PRIMARY purpose of a Site Qualification Visit (SQV) conducted by a CRA?

Accepted Answer

To assess the site's capability and resources to conduct the clinical trial

Answer

To train site staff on the study protocol procedures

Answer

To collect completed Case Report Forms from previous studies

Answer

To deliver investigational product to the site pharmacy

Question 2

During a Site Initiation Visit (SIV), which of the following is the CRA's MOST critical responsibility?

Accepted Answer

Ensuring all site staff are trained and documented on the protocol before enrollment begins

Answer

Reviewing all previously published literature on the investigational product

Answer

Requesting a list of all patients who may be eligible for the study

Answer

Submitting the final Clinical Study Report to the IRB

Question 3

Which document must be reviewed and filed in the Trial Master File (TMF) BEFORE initiating a clinical trial site?

Accepted Answer

IRB/IEC approval letter and approved informed consent form

Answer

Final signed Clinical Study Report

Answer

Completed database lock confirmation

Answer

Post-market surveillance report

Question 4

What is the primary goal of a Site Close-Out Visit (COV)?

Accepted Answer

To resolve all outstanding issues, account for investigational product, and ensure proper archiving of records

Answer

To randomize the final cohort of study subjects

Answer

To submit the IND application to the FDA

Answer

To conduct final statistical analysis of collected data

Question 5

Which of the following is a key item verified during a site qualification visit regarding investigator qualifications?

Accepted Answer

The investigator's current medical license, CV, and relevant training and experience

Answer

The investigator's publication count in peer-reviewed journals

Answer

The investigator's personal financial statements

Answer

The number of vacation days the investigator takes annually

Question 6

At a Site Initiation Visit, the CRA discovers the site's designated pharmacy lacks proper temperature-controlled storage for the investigational product. What should the CRA do?

Accepted Answer

Immediately halt the site initiation and require corrective action before enrollment begins

Answer

Allow enrollment to begin but document the finding in the monitoring report

Answer

Instruct the site to store the product at room temperature temporarily

Answer

Report the finding to the FDA directly without informing the sponsor

Question 7

Which of the following best describes the Trial Master File (TMF) in the context of site initiation?

Accepted Answer

A comprehensive collection of essential documents that individually and collectively permit evaluation of the conduct of a trial

Answer

A file containing only the financial agreements between sponsor and site

Answer

A database used exclusively by the FDA to evaluate clinical trials

Answer

A summary document generated only after study completion