A clinical trial is the controlled clinical testing in human subjects of an investigational drug, device, or diagnostic (or a comparison of drugs, devices, or diagnostics) to evaluate their efficacy and safety. A clinical trial always involves human subjects and the testing of a drug, device or diagnostic. This section covers clinical trials that are supported by for-profit companies like pharmaceutical companies or device manufacturers, by the federal government, or by non-profit organizations. An investigational new drug application (IND) or investigational device exemption (IDE) are the mechanisms by which regulatory authorities approve and monitor the testing of investigational drugs and devices in clinical trials.
When a clinical trial is labeled investigator-initiated, it means that the UAB Principal Investigator (PI) wrote the protocol, rather than the sponsor. This means the PI has made the intellectual contribution to the project, and the sponsor is providing only funding and/or the study drug, device, or diagnostic. Generally, UAB will hold the IND/IDE in this circumstance. Sponsor-initiated clinical trials are those in which a sponsor (company/person), rather than the PI, writes the protocol and also provides funding and the study drug, device, or diagnostic. Generally, the sponsor will be the holder of the IND/IDE.
Industry-sponsored clinical trials that meet UAB’s definition of a clinical trial (see In-depth page linked below) are eligible for the clinical F&A rate of 30%. If the project does not meet this definition, it will be subject to the DHHS negotiated F&A rate (see applicable F&A link below) for other sponsored activities, calculated on the Modified Total Direct Cost (MTDC) basis.
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