Proposal Development and Submission

Clinical Trials

Operational Definition of a Clinical Trial

From the Data and Safety Monitoring (DSM) Guidelines for Clinical Trials 2003 - University of Chicago, the Division of the Biological Sciences and the Prtizker School of Medicine

A clinical trial is operationally defined as a prospective study involving human subjects that is designed to answer specific questions about the effects or impact of particular biomedical or behavioral interventions. Such studies may include drugs, treatments, devices, or behavioral or nutritional strategies.

In the area of molecular or imaging diagnostics, a study is a clinical trial if it uses the information from the diagnostic test in a manner that somehow affects medical decision-making for the study subject. In this way the information from the diagnostic test may have an impact on some aspect of outcome, and assessment of this outcome may be a key goal of the trial. By contrast, studies that do not use information from the diagnostic test in any manner that can affect the outcome of study subjects, but whose objective is only gathering data on the characteristics of a new diagnostic approach, are not clinical trials and are not covered by this DSM policy, unless performing the diagnostic test itself imposes some risk on study subjects.

Behavioral clinical trials include studies of interventions with the goals to increase behaviors (e.g., cancer screening, physical activity, fruits and vegetable intake), eliminate or reduce behaviors (e.g., smoking, sun exposure) and /or improve coping and quality of life or reduce the negative sequelae of treatment. Observational studies and those that do not test interventions are not considered clinical trials.

For the purposes of University of Chicago study agreements and the application of the appropriate indirect cost (F&A) rates, the following scenarios, with respect to the above definition, pertain:

  • For studies conducted under federal sponsorship, the negotiated federal indirect cost rate applies;
  • For preclinical and observational studies supported by commercial sponsors, the rate for for-profit sponsors funding basic research (including animal studies), instruction, or other sponsored activities applies (40% total direct costs);
  • For studies testing interventions, or whose ultimate intent is to provide data to the FDA, the clinical study indirect cost rate of 25% applies. For anomalous cases concerning whether the clinical study cost rate applies, the Biological Sciences Dean’s Office will be consulted.

*

Helpful Links
squares