The document outlines various regulatory documents that must be maintained at clinical research sites, including an investigator's agreement signed by the principal investigator taking responsibility for the study conduct, financial disclosure forms for study staff, protocol signature pages signed by the PI and staff training logs to document that all personnel are qualified to perform assigned tasks. Other required documents include IRB approvals, subject enrollment logs, investigational product accountability records, safety reports, correspondence between the site and sponsor/IRB, a CLIA waiver if biological samples are collected, and an investigator's brochure containing information on the study drug.