The mission of the Office of Clinical Trials Administration (OCTA) is to provide comprehensive contracting for investigators 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 eligibility for using the special Clinical Trial Indirect Cost Rate of 30% (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 Trials Administration (OCTA) has the responsibility and authority to negotiate industry sponsor-initiated clinical trials while Office of Contracts and Grants (OCGA) negotiates UC San Diego Investigator initiated clinical trials.
Effective August 1, 2016, the OCTA Clinical Trial Agreement Request Form will no longer be used. All Health Science departments have been onboarded to ePD.
Training and Approval Access is required for the proposal creators in order to create a new Clinical Trial proposal in ePD at: http://blink.ucsd.edu/research/preparing-proposals/proposal-development/epd/access-use.html
For questions, please contact OCTA@ucsd.edu or 858-822-2940.