Remember to get cost estimates for services in advance of grant submission.
Describing the CTSC in a Grant Application
The CTSC provides key services to investigators, trainees, and staff to facilitate clinical and translational research. Investigators who wish to include CTSC services and programs in their grant applications may use the following descriptive language. It is important to ensure that the costs of any proposed CTSC services are determined prior to submission of the application. The best way to obtain information for budgets and budget justifications is to request a consultation with the desired service manager by using the request for services application. The application requires that the investigator supply basic information about the proposed research so that the request can be directed to the appropriate program manager. Alternatively, investigators may contact individual program managers for specific information. A list of program contact staff is provided on the CTSC contact page.
UC Davis Clinical and Translational Science Center (CTSC)
The UC Davis CTSC was established in October 2006 with a $24.8 million Clinical and Translational Science Award from the NIH. The CTSC, now one of 61 NIH-supported centers nationally, is focused on enhancing the study of human health and disease, and bringing new treatments more rapidly to patients and communities (www.ucdmc.ucdavis.edu/ctsc/). The CTSC, physically housed in a specially renovated 16,000 sq. ft. facility on the Sacramento campus, draws talent and leadership from departments and divisions across the Davis and Sacramento campuses as well as community and institutional partners in the region. The CTSC is an academic home for innovative and collaborative research across the UC Davis campus and is a part of a national consortium bridging basic, translational, and clinical research using a transformative approach. The consortium is designed to:
- Encourage the development of new methods and techniques to enhance clinical and translational research.
- Improve training and mentoring to ensure that new investigators are educated in the conduct of clinical and translational research.
- Enhance the ability of investigators to navigate the increasingly complex research system.
- Design new and improved clinical research informatics tools.
- Assemble multidisciplinary teams that cover the spectrum of clinical and translational research.
- Forge new partnerships with private and public entities that will help transform the clinical enterprise.
A key feature of the UC Davis CTSC is an education program focused on "team science" and an extensive collaborative culture to support this effort across UC Davis schools, colleges, and centers. The UC Davis CTSC has implemented several programs to enhance communication, encourage sharing, facilitate research, and train multidisciplinary teams that will conduct clinical and translational research in the future. Key programs in the CTSC include the following: Biomedical Informatics; Research Education, Training, and Career Development; Translational Technologies, Methodologies, and Resources; Pilot Translational and Clinical Studies; Biostatistics, Epidemiology, and Research Design; Research Ethics; Regulatory Knowledge and Support; a Clinical Research Center; and Community Engagement. Through these programs, the UC Davis CTSC transforms research and aids in supporting and facilitating new collaborative scientific discoveries that will bring new techniques and therapies into medical practice, and help to solve complex medical problems.
Research Education, Training and Career Development
The goal of this program is to create a cadre of multidisciplinary clinical and translational researchers through effective research education, training, and career development. Trainees and junior faculty acquire state-of-the-art multidisciplinary skills in clinical and translational research through three training mechanisms: an innovative T32 pre-doctoral program in “team science” for medical and graduate students; an enhanced K30 Mentored Clinical Research Training Program for junior faculty; and a K12 Mentored Career Development Program for junior faculty. These training programs are also highly integrated with several other UC Davis training programs in translational research, including the NIH-funded Building Interdisciplinary Research Careers in Women's Health (BIRCWH) program; the NIH-funded FUTURE program, the UC Davis Stem Cell Training program supported by the California Institute for Regenerative Medicine (CIRM); and NIH-supported K12 programs in Emergency Medicine and Oncology.
Pilot Translational and Clinical Studies
The Pilot Translational and Clinical Studies program aims to spark innovative and collaborative scientific endeavors by supporting and facilitating robust new research paradigms, technologies, and tools, and through partnerships that enhance team science. The CTSC has circulated calls throughout the campus community for applications on targeted topics, and has maximized and leveraged opportunities throughout UC Davis including other NIH-supported centers and programs. All funded investigators and the titles of their projects are listed on the CTSC website to highlight their success and innovation. In addition, potential new research opportunities are noted, and where appropriate, investigators are directed to the Translational Technologies, Methodologies, and Resources program to determine potential commercialization of their work.
Translational Technologies, Methodologies, and Resources
The overriding objective of the Translational Technologies, Methodologies, and Resources program is to serve as a facilitator, encourage investigators to form multidisciplinary partnerships, and link investigators with the resources needed to undertake novel studies. To implement these objectives, the program provides ready access to core services and facilities through the Facilities, Cores, and Resources website; organizes collaborative workshops and symposia on key thematic areas that are frequently associated with calls for pilot project applications; and supports local and national translational research initiatives.
The Community Engagement program is a major resource linking investigators and community partners. The program is focused on implementing the CTSC mission of building capacity and infrastructure for clinical and translational research among investigators, health care providers, and community-based organizations. Partners include California health agencies and elected officials involved in health and healthcare issues. The CTSC has built capacity for community-engaged research, including a research agenda responsive to community priorities; a Research and Education Community Advisory Board; and a consultation service for investigators that conduct practice-based research and for community members seeking academic research expertise.
The Biomedical Informatics team helps develop strategies to manage clinical and translational research data and maintains a registry of volunteers. Programmers are available to assist investigators with database design and management, secure data sharing, and electronic data capture. In addition, there is expertise available to help develop data specifications and consistent terminology, extract cohorts of de-identified data to establish study feasibility, provide cohorts of potential study candidates from electronic medical records and aggregate databases, and assist in preparation of a data set for statistical analysis. Through the Biomedical Informatics program, researchers have access to Volunteer Registry, SciVal, Cohort Discovery, REDCap, Velos, and Data Explorer.
Biostatistics, Epidemiology, and Research Design
The Biostatistics program strengthens research plans through study design, analysis, and consultation. Expertise is available to help develop protocols, statistical plans, data safety monitoring plans, data analysis, and contribute to the statistical sections of grant applications, abstracts, and manuscripts.
The CTSC Research Ethics program provides consultations to researchers who seek advice regarding ethically complex aspects of their biomedical research. The service is available to assist investigators throughout the life of a research project, from the initial design phase of the study through dissemination of research findings. The program also delivers courses on research ethics to students in graduate and professional training programs, along with regularly-scheduled
Clinical Research Center
The CTSC Clinical Research Center (CCRC) is a 3,500 square foot outpatient clinic governed by the National Center for Advancing Translational Sciences (NCATS), a center of the National Institutes of Health (NIH) under the Clinical and Translational Science Award (CTSA) program. It provides flexible, carefully monitored clinical resources necessary for patient-oriented research focusing human health and/or disease. Resources include unique equipment and protocol administration tools, as well as highly experienced staff who are trained in human subjects' protection, good clinical practices, protocol implementation, and compliance, thus ensuring the quality of data collected and the integrity of the research. The CCRC has four infusion chairs, a single hospital bed, a procedure room, two general exam rooms, two private interview/testing rooms, two phlebotomy stations, an exercise physiology lab with a DXA machine, a specimen processing room, as well as expert research personnel trained to implement protocol-specific activities and collect data. Highly skilled clinical research nurses implement protocol-specific procedures and provide direct nursing care for all subjects enrolled in research studies. The nurses' areas of clinical expertise vary to accommodate a wide spectrum of clinical research strategies and disciplines. CCRC nurses ensure patient safety and protocol fidelity. They are certified in chemotherapy administration, moderate sedation and ACLS/PALS. A nurse practitioner is available to provide expanded services to investigators. Highly skilled laboratory staff support investigators with sample collection, simple/complex sample processing; DNA/RNA isolation; preparation of samples for proteomics and flow cytometry; multiplex cytokine/chemokine and metabolic analyses. Clinical research coordinators are available to aid investigators with regulatory support, subject recruitment/visits and budget development. The research dietitian performs nutritional status assessments; food record processing and analysis; nutritional education/counseling to optimize health status and research protocol adherence; and metabolic and calorie-controlled meal planning. An exercise physiologist performs metabolic, exercise, and spirometry testing, body composition/bone density measurements, and provides data analysis for investigators.
Regulatory Knowledge and Support
The Regulatory Knowledge and Support program provides assistance to investigators, scholars, and staff with the regulations and best practices that guide clinical research. The Clinical Trial Resource Group facilitates compliance with Good Clinical Practice, local, state, and federal regulations (e.g., IRB, HIPAA, Informed Consent, and FDA), Medicare and private payer cost analysis, budgeting and billing, and resources to help monitor, mentor, and foster quality assurance. The Program leads SoCRA certified training opportunities including a diverse range of topics and provides a Coordinator Training Program, Informed consent “Bootcamp,” and “Navigating the Clinical Trials Administrative Process.”