The CTRI has several interactive functional areas that provide resources, services, and guidance: the Center for Clinical Research (CCR); Education, Training, and Career Development (ETCD); Biomedical Informatics (BMI); Community Engagement (CE); Translational Research Alliance (TRA); Translational Research Technology (TRT); and Evaluation.
Center for Clinical Research (CCR)
This integrated unit to support clinical research provides the following services:
- Research Design and Biostatistics assists with the planning, analysis, and reporting of clinical trials; studies involving epidemiology, populations, and the risk of disease; 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 Support provides education and training to ensure that researchers are aware of safeguards and controls to protect human subjects. These programs include ethics train-the-trainer courses for CTRI faculty focusing on how to introduce ethics issues in the research environment and Research Ethics courses offered at UC San Diego and partner institutions.
- Regulatory Support collaborates with UC San Diego's Human Research Protections Program (HRPP) for reporting, education, and development of Institutional Review Board (IRB) processes. A regulatory service helps CTRI members with proposal submissions to the IRB.
- Center for Clinical Research provides space and staff to perform clinical research involving adults or children. This unit provides trained clinical staff, including nurses, clinical coordinators and a nutrition consultant; clinical research space; sample acquisition and processing; core facilities; and data entry and management; and budget preparation.
For further information visit the Center for Clinical Research (CRC) page
Education, Training, and Career Development (ETCD)
ETCD promotes research training by organizing institutional Roadmap training programs (i.e. TL1, KL2, and the Clinical Research Enhancement through Supplemental Training [CREST] Master's degree program); developing an educational pipeline of research training of diverse learners from undergraduate to faculty and include medical, pharmacy, nursing, and biotechnology disciplines; advancing mentoring through the Mentoring Academy; conducting research on training outcomes and methodology; and enhancing the diversity of trainees, mentors, and their projects.
- Roadmap TL1: A pre-doctoral research training program that provides short term and long term structured research experiences for medical and pharmacy students.
- Training for mentors to improve outcomes for young investigators.
- Clinical Research Enhancement through Supplemental Training (CREST) curriculum program: A modular curriculum that provides training in clinical research and can lead to a master's degree.
- Roadmap KL2: A mentored research program that supports junior faculty.
- MD-MAS program: A new five-year dual-track, concurrent MD/Masters of Advanced Science (MAS) degree program, successfully initiated in 2013, prepares participants for career in clinical research.
- Mentoring Academy: Established in 2013 to assess trainee and mentor needs, address these needs through training, and recognize excellence in mentorship.
- Seminar series and symposia: Supports numerous educational venues, including annual poster sessions for funded CTRI investigators, the Day of Translational Science symposium, and the Biomedical and Clinical Research Seminar series.
- Increasing diversity by partnering with diversity-focused initiatives to improve outreach to underrepresented learners, such as pairing undergraduates with TL1 scholars to provide mentoring.
For further information visit the Education, Training, and Career Development (ETCD) page
Biomedical Informatics (BMI)
BMI develops, pilots, launches, and manages informatics software systems, provides consultative services for investigators, and provides training in informatics:
- Velos eResearch is an integrated software system designed to assist investigators in managing their clinical research trials/studies. The web-based system integrates multiple tracking systems and standardizes clinical trial records, simplifying clinical trial management. It also links to the UC San Diego Health System's Epic Electronic Medical Record System to provide improved information and integration for clinical research projects. Velos eSample is a module of Velos eResearch that links biological samples to patient electronic medical records. Investigators can track where samples are stored and track multiple samples.
- REDCap (Research Electronic Data Capture) is a secure web application for building and managing online surveys and databases. The application also allows researchers to create projects and export data to Excel, SAS, and other statistical packages. CTRI offers training sessions and online tutorials for investigators who use REDCap.
- The Clinical Data Warehouse for Research (CDWR) mirrors the electronic medical record and allows researchers to perform de-identified searches for patient counts or identify potential research subjects through IRB-approved searches through a data concierge service.
- The Center for Computational Biology and Bioinformatics assists with design and analysis of genomic experiments, Next Generation Sequencing, and epigenetic studies. The staff provides a range of study support, from data analysis to manuscript preparation.
- The UC-Research eXchange (UC-ReX) tool allows researchers to search nearly 12 million patient records from medical center databases in a federated system for aggregated de-identified counts at UCSD, UCLA, UC Irvine, UC Davis, and UC San Francisco. Launched by the University of California Biomedical Research Acceleration, Integration and Development (UC BRAID), this first cross-campus clinical query system is capable of exchanging patient-level data (with IRB approval through a data concierge service), as well as aggregates (counts and descriptive statistics) across the five UC medical centers.
For further information visit the Biomedical Informatics (BMI) page
Community Engagement (CE)
Community Engagement links academic activities to a broad range of stakeholders in our community, including engaging the general public on matters of clinical and translational research and increasing collaboration with community-based agencies and providers. For CTRI investigators, research staff, and trainees, Community Engagement provides consultation on best practices and increases the capacity to engage the community. Among the key programs activities, the group:
- Builds partnerships with practitioners and patients at Palomar Pomerado Health, Rady Children's Hospital-San Diego, community clinics, and other health-related organizations and agencies such as the San Diego Blood Bank, and the general public.
- Educates the public about clinical research, translational researchers about community-based research, and community physicians about new treatments through health fairs, videos, and social media.
- Promotes research in health care disparities.
- Links investigators to potential research participants through novel web-based tools like ResearchMatch.
For further information visit the Community Engagement (CE) page
Translational Research Alliance (TRA)
TRA links clinical and translational investigators at UC San Diego, VA San Diego, Rady Children's Hospital-San Diego, and Palomar Pomerado Health with basic science researchers at the Salk Institute, the Burnham Institute, the La Jolla Institute of Allergy and Immunology (LIAI), the J. Craig Venter Institute (JCVI), and San Diego State University (SDSU) in order to foster collaboration and resource-sharing, and to decrease barriers to interaction. It also facilitates technology transfer and the development of novel therapies with our partner institutions and industry, and increases interaction with CONNECT and BIOCOM.
- The TRA promotes collaborations among CTRI's institutional and corporate partners; and establishes long-term relationships with multiple companies that provide guidance to the CTRI on the best ways to interact with the private sector.
- The Galvanizing Engineering in Medicine (GEM) program brings engineers and clinicians together to develop innovative technologies that can be applied to solving challenging problems in medical care. The program is a collaboration with the UC San Diego Institute of Engineering in Medicine.
- The program also oversees the Pilot Research Grants program to assure that funding opportunities are available to faculty throughout the consortium.
- William J. von Liebig Center offers consultation to pilot grant awardees on filing patents, developing business plans, seeking private funding, and other methods for commercializing university innovations. The Center is housed in the UC San Diego Jacobs School of Engineering.
For further information visit the Translational Research Alliance (TRA) page
Translational Research Technology (TRT)
TRT provides integrated laboratory services and collaboration involving biorepositories and biomarker analysis, as well as a translational technology seminar series.
- The CTRI Biorepositories collect, curate, and house human tissues and other biological samples from healthy individuals and those with selected diseases.
- The CTRI Laboratory specializes in quantitative measurement of biomarkers in human clinical specimens such as blood, solid tissue, urine, and sputum.
- Affiliated laboratories that collaborate with TRT include the fMRI Center for Neuroimaging, Proteomics/Mass Spectroscopy, and the Conrad Prebys Center for Chemical Genomics.
- The CTRI Biomarker Clinical Trial Service provides integrated training and support for clinical trials that evaluate drug mechanism of action.
For further information visit the Translational Research Technology (TRT) page
Defining the criteria for success and determining whether we meet our goals are essential to successful program development. We have developed a novel application of the Balanced Scorecard methodology, which aligns goals across the organization. This tool is traditionally used in business, but has been adapted for academic use by our Evaluation group. CTRI leadership is also independently evaluated annually by the External Advisory Board and the UCSD Academic Senate. Among its activities, the CTRI Evaluation group assesses how effectively the CTRI:
- Trains scientists to develop into independent and collaborative investigators, as determined by new projects, independent funding, ability to guide the project to completion, and publication of results.
- Ensures efficient utilization of resources.
- Demonstrates progress towards accomplishing annually determined goals.
- Adequately engages research partners in collaborative studies.
- Assesses programs to enhance diversity among our researchers, staff, and research participants and how well we engage the community.
- Obtains metrics across the UC system to improve processes and decrease regulatory burdens on investigators.
For further information visit the Evaluation page.