Clinical Trial: All FDA regulated trials and refers specifically to the controlled, clinical testing in human subjects of investigational new drugs, devices, 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.
Facilities & Administrative (F&A) costs: Those costs incurred for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of F&A expenses to the cost objectives served, it may be necessary to establish several pools of F&A costs. F&A cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived. See to 2CFR200.56.
Indirect costs: See Facilities & Administrative (F&A) costs.
Investigator: A person responsible for the conduct of the clinical research. If the research is conducted by a team of individuals, the investigator is the responsible leader of the team and may be called the principal investigator.
Principal Investigator: See Investigator.
Sponsor: Pharmaceutical, biotechnology or medical device company, or federal or state organization, or foundation, investigator or other entity that commissions, supervises and pays for a study.