A-8) Non- Industry Clinical Trial

Review date
Responsible office
Office of Sponsored Research

Definition

Primary sponsor is a government or non-profit entity. Award mechanism may be a contract, subcontract, cooperative agreement, or grant.

Awards given 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.

Examples
  • An NIH-sponsored FDA Phase II testing of one drug versus another such as AZT vs. 3TC.
  • An agreement with a pediatric AIDS Foundation to perform an FDA Phase IV clinical trial of a drug in children.
  • Blood testing done in a UCSF research lab of samples from an outside University that is conducting an FDA-approved clinical trial.
  • The controlled clinical testing of a protocol performed under the sponsorship of an approved national cooperative consortium for clinical trial services.
Overhead Consideration
Policy
Review Department/Signature Authority

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