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. These studies are most often conducted in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration (FDA), under an Investigational New Drug (IND) application or as IND exempt for drug studies (as Phase I, II, III, or IV), or under an Investigational Device Exemption for device studies, although studies can be designed with the sole purpose of collecting and analyzing data about approved drugs or devices in order to contribute to medical knowledge about the treatment of a disease or medical conditions. In the case of a non-FDA regulated drug, device, treatment or diagnostic (including dietary supplements), the study must use medical facilities and University personnel in the performance of the study. In all cases, the study must include the prospective enrollment of human subjects and the controlled testing of a drug, device, treatment or diagnostic under an approved protocol.
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). Retrospective chart reviews, analysis of existing medical data and records, laboratory research, animal studies, and federally funded projects are not categorized as clinical trials for purposes of applying the approved clinical trial indirect cost rate. The clinical trial IDC rate may not be used unless financial support for the clinical trial is provided by a for-profit, commercial entity, such as a pharmaceutical or device company. 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 and execute agreements that meet the above definition of a clinical trial when (i) under an industry developed protocol and (ii) funded by industry. Such industry sponsor-initiated and funded clinical trials are authored and funded by a pharmaceutical, device, biotech company, or for-profit Clinical Research Organization (CRO) whether directly or indirectly through another academic medical center or non-profit organization.The Office of Contract and Grant Administration (OCGA) has the responsibility and authority to negotiate and execute a broader spectrum of research agreements, including UCSD Investigator authored clinical trial protocols and clinical trials funded by the government or a non-profit entity.
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. Clinical trials must be submitted 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.