Office of Clinical Trial Administration

Mission Statement

The mission of the Office of Clinical Trial Administration is to provide comprehensive contracting and budget services for researchers and administrators to enhance their ability to achieve excellence in the clinical trial arena while adhering to University policies.

Clinical Trial Definition

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. Financial support for the clinical trial must be provided by a for-profit entity.

The above definition of a clinical trial is for the sole purpose of determining the projects eligible for using the special Clinical Trial Indirect Cost Rate of 26% (total direct cost). This definition has no impact on the intellectual property policies applicable to various types of agreements, the allocation and distribution of private indirect cost recovery, applicability of various policies (including FDA regulations) about disclosure of conflict of interest, or other policies of the University.

Who To Contact

The Office of Clinical Trial Administration (OCTA) has the responsibility and authority to negotiate industry initiated clinical trials while Office of Contracts and Grants (OCGA) negotiates investigator developed clinical trials.

The OCTA has a new Clinical Trial Agreement Request Form.  The updated form can be found by accessing the link for the "Clinical Trial Agreement  Request Form"  on the Forms page of this website.   Please use the revised from whenever submitting documentation for a clinical trial.