Clinical Investigation Core
About
Submit a Service RequestThe Clinical Investigation (CI) Core provides services and expertise to conduct clinical studies as well as access to longitudinal databases for epidemiologic and outcomes research. The CI Core’s mission is to accelerate innovative, high-quality, person-centered clinical, translational, and implementation science (IS) research to prevent new HIV infections, advance the quality and health span of persons affected by HIV, dismantle barriers to care, and promotes interventions, and approaches to end the HIV epidemic.
The Cl Core is primarily administered at the UC San Diego Antiviral Research Center (AVRC). The AVRC has multiple examination rooms, laboratory and pharmacy facilities, a data center, conference room, library, and freezers for temporary storage of specimens. Part of the AVRC clinic’s mission has been to document historical outcomes for thousands of patients who have received HIV care at the clinic and through the UC San Diego Medical Center. A variety of clinical, laboratory, and administrative datasets have been assembled since 1990 on more than 6,000 patients. These databases were assembled to improve quality of care and to facilitate observational research on natural history, treatment outcomes, quality of life, and costs of care. Access to de-identified datasets is available to researchers through CI Core services.
Services
The CI Core provides access to rich clinical data and biospecimen resources that support HIV-related research across diverse populations. These resources are not limited to the Owen Clinic; rather, they are part of a national, well‑characterized research network that enables investigators to assess feasibility and pursue analyses efficiently.
Requesting Services
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
We strongly encourage investigators to reach out early with questions—particularly if you are unsure whether samples or data exist for your population of interest.
Our goal is to make these resources accessible and to actively support investigator engagement, from project conception through implementation.
Clinical Data, Specimen Repository, and Investigator Access
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
How Investigators Determine Sample Availability
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:
- Reviewing CNICS documentation (linked above), which outlines specimen inventories and cohort characteristics.
- Consulting searchable resources provided through CNICS (e.g., structured data dictionaries and feasibility tools).
- 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.
FAQs
What kinds of clinical data are included in the Owen Clinic database?
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.
Do I need IRB approval to obtain data from the Owen Clinic database?
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.
Who has to approve requests for data from the Owen Clinic database?
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.
Are there additional requirements for investigators receiving 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.
What statistical services are available from the Core?
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.
Can the Core help with a Safety Monitoring Plan?
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.
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