Overview of the Clinical and Translational Research Institute (CTRI)
The Clinical and Translational Research Institute is a multi-institutional organization based at UC San Diego, under the directorship of Gary S. Firestein, MD, Dean of Translational Medicine. Dr. Firestein was named Associate Vice Chancellor of Translational Medicine in late 2010. This new position integrates translational research activities across the School of Medicine, the Medical Center, and the School of Pharmacy and Pharmaceutical Sciences.
As an administrative home for multidisciplinary research, the CTRI is ideally suited to support Health Sciences’ research training programs. The CTRI is partially funded by a Clinical and Translational Science Award from the National Center for Advancing Translational Science (NCATS). It also receives substantial support from UC San Diego Health Sciences, including funding for (a) institutional KL2 awards; (b) clinical coordinators and statisticians; (c) Pilot Project grants; (d) the purchase and implementation of the Velos clinical trial management software (see below); and (e) space: 25,000 sf in the East Campus Office Building (current location) and the 359,000-sf, $269 million Altman Building (scheduled for opening in 2016).
The Institute’s cores and services are administered by six divisions: Education, Training and Career Development; Center for Clinical Research; Translational Research Technology; Biomedical Informatics; Translational Research Alliance; and Community Engagement. Each Division incorporates training and/or formal education into its activities.
ACTRI Organization Chart
Center for Clinical Research (CCR)
This Division has five sections:
Design and Biostatistics, offering assistance with many research activities, including the planning, conduct, analysis, and reporting of clinical trials; studies involving epidemiology, populations, and the risk of disease; translational research, especially projects involving genomics; scientific computing for data analysis and scientific graphics; analysis of high-dimensional data generated by –omics fields and imaging research; database design and management; IND protocols and other technical issues; and revisions of grant applications.
Ethics, which offers comprehensive educational programs to assure that research has the appropriate safeguards and controls to protect human subjects. This includes daylong ethics train-the-trainer courses to CTRI faculty on how to introduce ethics issues in the research environment, and Research Ethics courses to UC San Diego and partner institutions.
Regulatory, which interacts with UC San Diego’s Human Research Protections Program (HRPP) for reporting, education, and development of Institutional Review Board (IRB) processes. HRPP staff members ensure timely processing and regulatory review of clinical protocols through four biomedical IRBs.
Clinical Research Services, which assists investigators with the actual performance of clinical research involving either adults or children. It provides trained clinical staff, clinical research space, sample acquisition and processing, nutrition consultation, core facilities, and data entry.
Clinical Coordinator Service, which provides trained clinical coordinators to investigators on an hourly recharge. Coordinators can be used for limited services or can be the assigned as the main coordinator on a study. Services available include IRB submissions, subject recruitment, scheduling, consenting subjects, generating case report forms, performing vital signs, etc.
Biomedical Informatics Division
This Division oversees the seven main resources in our Informatics infrastructure:
Velos eResearch, the primary clinical trial management system used by clinical investigators and sample repositories. This is an integrated, standardized, and powerful software for managing clinical trials that are large, multicenter, or that will benefit from linkage to the Electronic Medical Record of the Medical Center.
Velos eSample, a module of Velos eResearch that links biological samples to the Electronic Medical Record.
REDCap, (Research Electronic Data Capture) a free, secure web application for building and managing online surveys and databases.
The Clinical Data Warehouse for Research (CDWR), which allows researchers to query the Electronic Medical Record in a HIPAA-compliant manner and estimate how many UC San Diego Medical Center patients match a specified profile. The CDWR will provide patient diagnoses, outpatient visits, age, and gender, among a growing list of types of data.
The Center for Bioinformatics Analysis (CBA) assists with genomic experiments, Next Generation Sequencing, and epigenetic studies. The staff provides a range of study support, from data analysis to manuscript preparation. The Center also keeps budgets on track by estimating costs, identifying funding sources, and writing up grant support.
The UC-Research eXchange (UC-ReX) Data Explorer tool allows researchers to search 12 million de-identified patient records from medical center databases here at UC San Diego, as well as at UC Los Angeles, UC Irvine, UC Davis, and UC San Francisco. Launched by the University of California Biomedical Research Acceleration, Integration and Development (UC BRAID) consortium, this first cross-campus clinical query system is capable of exchanging patient-level data, as well as aggregates (counts and descriptive statistics) across the five UC medical centers and some of our key partner institutions. Also launched is a Data Concierge service that identifies patients and extracts identified, de-identified, or limited patient-level datasets from electronic medical records according to IRB approval for clinical research projects.
Training and Education, which is in the process of developing and delivering workshops, seminars, and didactic courses (including a new CREST module).
Translational Research Technology (TRT) Division
This Division consists of four sections offering a variety of services that can be used by UC San Diego scientists, CTSA consortium members, and trainees.
The CTRI Biorepositories prospectively collect, curate, and house human tissues and other biological samples from healthy individuals and those with selected diseases. Repository management is available to CTRI members.
Affiliated Biorepositories include samples from patients with HIV/AIDS, cancer, neurodegenerative diseases, and rheumatic diseases.
The CTRI Laboratory specializes in quantitative measurement of biomarkers in human clinical specimens such as blood, solid tissue, urine, and sputum. The Laboratory offers more than 125 validated assays, many of which are immunoassays and quantitative PCR.
Affiliated Laboratories include the fMRI Center for Neuroimaging, Proteomics/Mass Spectroscopy, Tissue Imaging, the Conrad Prebys Center for Chemical Genomics, Human Tissue Resources, and the UCSD Genomics Core at the Sanford Consortium.
Staffed by experienced faculty and research associates, the TRT works closely with other CTRI service providers to offer a complete solution from clinical sample acquisition through data analysis. In addition to assay performance, the laboratories offer consultation and hourly service rates.
Education, Training and Career Development Division
The directors of individual T32s can use and adapt the methods being developed by the Education Division to manage its Roadmap TL1, such as:
Evaluating the training program, its director, and its mentors and mentees
Curating the resulting data
Selecting mentors and matching them to mentees
Consultation on mentoring
Management of the Clinical Research Enhancement through Supplemental Training (CREST) curriculum, which is available to T32 trainees and to those who have completed the T32 program
Overseeing the expansion of CREST didactic offerings
Operating the Roadmap KL2 training program to which junior faculty can apply after completion of their T32 training
Community Engagement Division
The goal of this Division is to build new partnerships with practitioners and patients at Palomar Pomerado Health, Rady Children’s Hospital, community agencies, and the general public, in order to advance education, clinical research, and adoption of new treatments. Directors, faculty, and trainees of T32 programs will benefit from our CREST module (Health Care Disparities Research Methodology) and from our database of existing community partnerships. The latter will provide new investigators with an internal, experienced resource to help them reach communities.
Translational Research Alliance (TRA) Division
TRA’s Research Partners Unit promotes collaborations among the institutional and corporate partners of the CTRI—BIOCOM, CONNECT, the Institute of Engineering in Medicine, La Jolla Institute for Allergy and Immunology, Rady Children’s Hospital, Salk Institute, VA San Diego Healthcare System, Sanford-Burnham Institute, SDSU, and the J. Craig Venter Institute. Similarly, the International TRA Unit promotes research and corporate partnerships overseas. These two Units increase the number of potential collaborations for mentors and mentees, and provide networking possibilities for the latter once they complete their traineeships.
A third component of TRA, Pilot Research Grants, is the administrative home for several annual grant programs of particular value to junior investigators. Funding Opportunities include subcategories for Pilot Clinical Studies (up to $25,000 per award), Pilot Translational Studies (up to $25,000 per award), Pilot Innovative Technology Projects (up to $50,000 per award), Pilot Personalized Medicine Projects (up to $50,000), and Community Grants to assist new investigators with study design and regulatory submissions (up to $5,000 of in-kind CTRI services).
The William J. von Liebig Center, which is housed in the UC San Diego Jacobs School of Engineering and focuses on commercialization of university innovations, guides Pilot Research Grant awardees at no charge on filing patents, developing business plans, and seeking private funding. Mentors in T32 programs are eligible for these awards.