Review date
Responsible office
Office of Sponsored Research
Definition
Primary sponsor is a for-profit entity and terms are defined by contract and involve multiple organizations.
An award for the controlled, clinical testing in human subjects of Investigational New Drugs (INDs), Investigational Devices (IDEs), treatments, or diagnostics, or comparisons of approved drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes. Such studies may be conducted under an industry-developed protocol or an investigator-developed protocol.