The rates approved in this agreement are for use on grants, contracts, and other agreements with the Federal Government, subject to the conditions in Section III.
Contact: Financial Accounting, (205) 934-9330

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Clinical Trials Definition UAB defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”

UAB also considers evaluations that directly lead to the development or conduct of a clinical trial to meet the clinical trial definition (e.g., Phase 0, preparatory work). This can include feasibility assessments utilizing existing databases containing data from human subjects. Additionally, funded efforts undertaken by data coordination units can meet the definition of clinical trials if the studies that they are developing and managing are clinical trials as defined above.

Examples of intervention include drugs; small molecules; compounds; biologics; devices; procedures (i.e., surgery); delivery systems (i.e., face-to-face interviews); strategies to change health-related behavior (i.e., diet, cognitive therapy, exercise, development of new habits); or prevention, diagnostic, or treatment strategies. A clinical trial always involves: (i) human subjects and (ii) the testing of an investigational intervention or the testing of an approved intervention for an investigational purpose.

The Food and Drug Administration (FDA) classifies a clinical trial of a drug based on the study’s characteristics, such as the objective and number of human subject participants. There are five phases (see table).

Phase	Description
Phase 0	Exploratory studies involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (e.g., screening studies, microdose studies).
Phase I	Studies usually conducted with healthy human subject participants that emphasize safety. The goal is to identify the drug's most frequent and serious adverse events and, often, how the drug is metabolized and excreted.
Phase II	Studies that gather preliminary data on effectiveness (whether the drug works in people with a certain disease or condition). Participants receiving the drug may be compared to those receiving a placebo or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Phase III	Studies that gather more information about safety and effectiveness by studying different human subject populations and dosages, and by using the drug in combination with other drugs.
Phase IV	Studies occurring after the FDA has approved a drug for marketing. These include post-market requirement and commitment studies that gather additional information about a drug's safety, efficacy, or optimal use.

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 or device. If there is an FDA-regulated product involved and it is considered to be investigational, generally the sponsor will hold the IND/IDE.

Industry-sponsored clinical trials that meet UAB’s definition of a clinical trial (see Clinical Trial F&A Flowchart) are eligible for the clinical F&A rate of 30%. All other clinical trials will be subject to the DHHS negotiated F&A rate (see UAB Rate Agreement).

The University of Alabama at Birmingham's (UAB) Facilities and Administrative (F&A) rate reflects the cost of real expenses that incur during the course of conducting research. These costs are classified as "indirect" because they are not easily identified with a specific project and do not appear as line items on budgets. Items that are included within the F&A cost rate are building and equipment depreciation; the portion of construction and facilities maintenance dedicated to research; recurring expenses such as utilities, telecommunications, hazardous waste disposal, security and fire protection, and liability insurance; institutional administration, which includes but is not limited to, accounting, legal, counsel, compliance, personnel, and sponsored programs administration; and research administration at the university, school, department, and division levels.

All industry-sponsored clinical trial agreements, that meet the reduced F&A Rate criteria here, processed by the UAB Office of Sponsored Programs (OSP) should include the F&A rate of 30% to be applied for budgetary purposes, and ultimately on all cash received. If they do not meet the criteria, they and Investigator Initiated Trials should include 36% MTDC F&A rate in addition to the direct costs.