Site Initiation, Qualification, and Close-Out Procedures Flashcards

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

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

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

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

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

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

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

Answer: IRB/IEC approval letter and approved informed consent form

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.

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

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

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.

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

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

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.

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?

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

Inadequate storage conditions violate GCP and could compromise product integrity and subject safety; enrollment must not begin until compliant storage is confirmed.

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

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

Per ICH E6, the TMF contains essential documents that allow reconstruction of trial conduct and is maintained by both the sponsor and investigator throughout the trial.