Responsibilities (SOP) (doc, 71kb)
Lists the Consortia responsibilities during the conducting of annual/interim visits.

Clinical Site Annual (Interim) Monitoring Report (doc, 130kb)
Use to document findings of annual/interim site monitoring visits. It can also be used as a preparation worksheet for annual/interim visit tasks.

Pharmacy Visit Report (doc, 82kb)
Use to document findings of pharmacy visits. It can also be used as a preparation worksheet for pharmacy visit tasks.

Site Monitoring Visit Log (doc, 46kb)
Use to document monitor and site staff attendance during the site visit.

Per PID Finding Sheet for On-Site Chart Review (doc, 45kb)
May be used as a communication tool for findings per participant.

Preliminary Report of Monitoring Findings (doc, 47kb)
Use to document initial findings of an annual/interim site visit.

Examples of Major and Lesser Deficiencies (doc, 104kb)
Use as a guide to categorize severity of deficiencies found during a site monitoring visit.

Site Visit Report Timeline (doc, 62kb)
Use to identify standard timeframes for distribution of site visit reports (initiation, annual/interim or close-out).

Action Item - Site Response Form (doc, 52kb)
May be used to list action items from a site visit and capture site responses.