Investigator site file (ISF)

In Documents & records

Also known as: site file, regulatory binder

The investigator site file is the site's own collection of essential documents for a trial. It holds approvals, signed agreements, staff CVs and training records, the delegation log, and correspondence. Monitors review it at every visit, and inspectors will ask for it first.

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Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.