A Site Initiation Visit (SIV) is a meeting conducted before a clinical research site begins enrolling participants in a clinical trial. The SIV helps ensure investigators and site staff understand the study protocol, their responsibilities, applicable regulatory requirements, and the processes and systems needed to conduct the study appropriately.
During an SIV, a sponsor or contract research organization (CRO), often through a clinical research associate (CRA), may review the study protocol, informed consent process, participant eligibility and recruitment procedures, safety reporting requirements, investigational product management, data collection and documentation, regulatory records, and study-specific systems. The visit may also include confirming that required approvals, essential documents, training, facilities, equipment, and other resources are in place before the site begins study activities.
A successful SIV helps establish expectations for study conduct and confirms that site personnel are prepared to follow the protocol, Good Clinical Practice (GCP), and applicable regulatory requirements. Effective site initiation can support participant protection, protocol compliance, data quality, and efficient study execution.