Clinical Investigation Core

Access to CNICS data or biospecimens follows an established review process coordinated through the CI Core and CNICS governance. The CI Core provides hands-on support with:

• Feasibility discussions
• Determining appropriate datasets or specimen types
• Navigating submission and approval processes
• Connecting investigators with methodologic or analytic expertise

The CI Core strongly recommends early engagement for clinical, behavioral, and implementation science proposals to determine feasibility, clinic fit, study overlap, and to provide recommendations for effective recruitment strategies.

Our goal is to make these resources accessible and to actively support investigator engagement, from project conception through implementation.

The University of California San Diego CFAR participates in the CFAR Network of Integrated Clinical Systems (CNICS), a multi-site clinical cohort that integrates:

• Longitudinal clinical data derived from routine HIV care
• Demographic, treatment, and outcomes data
• Linked biospecimens collected using standardized protocols
• Information about available datasets, specimen types, and participating sites is maintained centrally through CNICS.

Comprehensive and up-to-date details are available via the CNICS website:

This site provides investigators with:

• Detailed descriptions of available specimen types (e.g., plasma, serum, PBMCs)
• Information on populations represented (e.g., age, sex, race/ethnicity, transmission risk, comorbidities)
• Data elements and collection time points
• Governance and access procedures

Investigators—including early stage and those new to SD CFAR—do not need prior engagement to assess feasibility. Sample and data availability can be determined by:

1. Reviewing CNICS documentation (linked above), which outlines specimen inventories and cohort characteristics.
2. Consulting searchable resources provided through CNICS (e.g., structured data dictionaries and feasibility tools).
3. Submit a service request and engage directly with the CI Core to discuss specific populations or scientific questions.

We recognize that navigating large repositories can feel like a barrier, particularly for emerging investigators. To reduce this, our CI Core team can help investigators identify whether samples relevant to a specific population or research question are available and guide next steps.

Cite CNICS
Support CNICS by citing them in your publications, abstracts and grants.

The Owen Clinic database includes diagnoses, medications, laboratory tests, and quality-of-life assessments documented on patients under care at the Owen Clinic since 1995.

In general, an IRB-approved research protocol is required. We can, however, provide summary data that have no patient identifiers to assist investigators in making sample size and power calculations for grant submissions.

The co-directors of the Clinical Investigation Core review data requests and assign them a priority based on scientific merit, number of hours required to construct the requested dataset, and number of competing requests for Core services.

The Core is required to document how and to what extent our services are used, and how our services are leveraged to support successful grant applications and publications. Therefore, if you would like to use core services, please use our Service Request form. In addition, any conference presentations or publications that resulted in whole or in part from contributions of the CFAR Clinical Investigation and Biostatistics Core should acknowledge CFAR support as follows: "This work was performed with the support of the Clinical Investigation and Biostatistics Core of the UC San Diego Center for AIDS Research (AI036214)." If any grants were awarded based in part on services provided by the Core, we request that you contact us so we can collect information about the award.

Core services can be provided to help plan a clinical project, provide sample size calculations, write brief analytic plans for grants and to perform concisely defined analyses. Full statistical support for major clinical research projects is beyond the scope of the Core; it is more the function of the Core to help investigators apply for grants that would then contain sufficient funding for statistical services. All requests are prioritized based on scientific merit and number of competing requests.

The Core offers periodic interim safety reviews for single-site investigator-initiated clinical research projects. We can also help investigators design monitoring plans and assist in assembling a Data and Safety Monitoring Board. However, full DSMB services are beyond the scope of the Core.

If work performed for you at the CFAR Clinical Investigation Core results in publication, please acknowledge us with the following statement so that we may continue to bring you excellent service: "This work was performed with the support of the Clinical Investigation Core of the UC San Diego Center for AIDS Research (AI036214)."

Clinical Investigation Core faculty and staff are closely associated with two UC San Diego HIV treatment facilities. Office hours are 8:00 a.m. to 4:30 p.m., Monday through Friday. - AntiViral Research Center (AVRC): Behind the UC San Diego Medical Center in Hillcrest. 220 Dickinson Street, Suite A, San Diego, CA 92103-8208. Phone: 619-543-8080. Fax: 619-543-5066. - Owen Clinic: Third floor of the Ambulatory Care Center (ACC). 4168 Front Street, Third Floor, San Diego, CA 92103. Phone: (619) 543-3995. Fax: (619) 543-7841.