What is the F&A rate for industry-sponsored clinical trials?

Question

What is the F&A rate for industry-sponsored clinical trials?

Answer

We do not have a separately negotiated rate agreement for industry-sponsored clinical trials (i.e., clinical testing in human subjects of investigational new drugs, devices, treatment or diagnostics or comparison of approved drugs, devices, treatments, or diagnostics), but it is the national practice to charge 26% Total Direct Costs (TDC) for industry-sponsored clinical trials. All other sponsored clinical trials would use the institutional negotiated rate as a research project. In order to qualify as a clinical trial, it must be registered with clinicaltrials.govProjects involving animal subjects should not be classified as clinical trials.

Related Terms

Facilities and Administrative Costs (F&A Costs)