Collecting and reviewing Essential Documents in clinical trials ensures study staff are qualified and compliant. This post covers key checklist items and regulatory references to help teams prepare for audits, confirm experience, and align roles with delegation logs for inspection readiness.

The Site Initiation Visit (SIV) is a critical step in starting a clinical trial at a site. Scheduling requires the collection key documents and staff availability. Once confirmed, the SIV letter outlines the agenda, meeting details, required training, and pre-visit tasks. Whether in-person or virtual, a well-planned SIV ensures the site is prepared to begin enrollment, follow protocol requirements, and maintain regulatory compliance.