Clinical Trials

A clinical trial is defined as the controlled, clinical testing in human subjects of investigational new drugs, devices, treatments or diagnostics, or comparisons of approved drugs, devices, treatments or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes.

Federally-funded projects, projects funded by interest groups, charities or the State of California, retrospective chart reviews, analysis of existing medical data and records, laboratory research, and animal studies are not categorized as clinical trials for purposes of applying the clinical trial F&A cost rate.