A Site Investigator File (SIF) is the site-maintained collection of essential documents demonstrating compliant trial conduct and oversight.
It typically includes approvals, delegation and training records, protocol versions, safety communications, correspondence, and investigational product documentation. The SIF provides evidence that the investigator and site followed the approved protocol and maintained required regulatory records. Monitors and inspectors review the SIF to confirm participant protections, documentation quality, and adherence to GCP. A well-organized SIF reduces audit risk and supports faster issue resolution during monitoring visits.