CCRA Site Initiation, Qualification, and Close-Out Procedures 1

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

The SQV evaluates whether the site has adequate facilities, staff expertise, patient population, and regulatory infrastructure to successfully conduct the trial.

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

The SIV ensures all site personnel are adequately trained and that training documentation is complete before the first subject is enrolled.

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

IRB/IEC approval of the protocol and informed consent form is a regulatory prerequisite that must be on file before any study activities commence at the site.

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

The COV ensures all data queries are resolved, unused investigational product is reconciled and returned or destroyed, and all trial documents are archived per regulatory requirements.

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

ICH E6 requires that investigators be qualified by education, training, and experience to assume responsibility for trial conduct, which is verified via CV and licensure.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Site Initiation, Qualification, and Close-Out Procedures 1