title: US inspections of clinical investigation sites.
abstract: If the United States (US) Food and Drug Administration (FDA) receives the funding that it has requested, it plans to increase inspections of clinical investigation sites both in the US and abroad. This article discusses US clinical investigation requirements and guidance documents that should be reviewed when preparing for FDA clinical site inspections.
authors.affiliation: donawa@srd.it
authors.forename: M
authors.initials: M
authors.lastname: Donawa
mesh_terms: D019983:Guideline Adherence; D006801:Humans; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration