All federally and privately supported clinical trials listed in the registry of clinical trials at www.ClinicalTrials.gov are eligible for a Clinical Trial F&A rate.
UPDATE: Effective 9-1-2018, the clinical trial IDC rate will be 38%, applied to the project’s total direct costs.
Other clinical trials must meet the following conditions to qualify for the Clinical Trial F&A rate:
- The trial involves:
The testing of investigational new drugs, devices, treatments, interventions or diagnostics, or alternative indications of approved drugs, devices, treatments, interventions or diagnostics, or
The collection or review of data generated or acquired in a clinical setting for the purpose of assessing the safety, efficacy, benefits, costs, adverse reactions or outcomes; and
- Contact with human subjects or the review of patient care clinical data;
- Performed in an off-campus clinical setting or patient care facility; and
- Funded by an industry sponsor.
Preclinical laboratory studies or studies in animals are not included under the term clinical trial. For more information, see Standards for Privately Funded Clinical Trials (PDF).