Clinical trials
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.
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.