A Site Qualification Visit (SQV) is an evaluation conducted before a clinical research site is selected to participate in a clinical trial. During an SQV, a sponsor, contract research organization (CRO), or clinical research associate (CRA) assesses whether the site and investigator have the capabilities, resources, facilities, personnel, and participant population needed to conduct the proposed study appropriately.
An SQV may include reviewing the investigator’s qualifications and research experience, evaluating site facilities and equipment, assessing staffing and training needs, discussing the study protocol and recruitment expectations, and reviewing the site’s processes for regulatory documentation, investigational product management, data collection, and participant safety.
The information gathered during the SQV helps sponsors determine whether a research site is suitable for the trial and identify potential challenges before study activation. Effective site qualification can support regulatory compliance, study quality, participant protection, and efficient trial execution.