The CTSC Clinical Research Center (CCRC) provides clinical research expertise and resources to biomedical investigators. Resources include unique facilities and equipment, as well as highly experienced staff who are trained in human subjects’ protection, good clinical practices, protocol implementation, and compliance.
The CCRC ensures that flexible, carefully monitored clinical resources necessary for safe and compliant patient-oriented research are available to investigators conducting studies relevant to human health and disease. CCRC staff are available to support research activities throughout the UC Davis Health System, as well as communities within Sacramento and neighboring counties, including participants’ homes. The range of study support can be as simple as a single blood draw or as complex as an investigational, Phase I infusion with frequent serial pharmacokinetic blood sampling. If you have questions about the services and facilities available, please contact Nicole Hansen, R.N., M.S.N. at email@example.com.
Clinical Research Nurse Services
Clinical research nurses implement protocol-specific procedures and provide direct nursing care for all patients enrolled in research studies. The nurses' areas of clinical expertise vary to accommodate a wide spectrum of clinical research strategies and disciplines. All CCRC nurses are committed to patient safety, protocol fidelity, quality data collection and upholding the Experimental Subject’s Bill of Rights. Each nurse is certified in chemotherapy administration, moderate sedation and ACLS/PALS.
Nurse Practitioner Services
A nurse practitioner (NP) reviews all protocols to establish protocol workflow, orders, flow sheets and to determine training needs for staff to ensure patient safety and protocol fidelity. In addition, the NP is available to perform more complex clinical procedures such as specialized exams, first dose administration and skin/fat tissue biopsies.
Clinical Research Coordinator Services
Clinical research coordinators provide supplemental regulatory and study visit support to CCRC investigators and serves as a primary resource for clinical research coordinators accessing CCRC support.
The exercise physiologist measures body composition, bone density, total body water, energy metabolism and expenditure, resting metabolic rate, cardio-respiratory fitness, and exercise stress tests. In addition, the exercise physiologist can provide data analysis for investigators.
A research dietitian performs nutritional status assessments, food record processing and analysis, nutritional education/counseling to optimize health status and research protocol adherence, and metabolic or calorie-controlled meal planning.
The laboratory staff provide support to investigators with simple-to-complex sample processing, DNA/RNA isolation, multiplex cytokine/chemokine and metabolic analyses, and preparation of samples for proteomics and flow cytometry.
Phlebotomy services are available for sample collection in our clinic, other UC Davis locations, local community sites or at the homes of study patients.
Research Education and Training
Educational and training opportunities are available to any member of the research team, including student nurses, new clinical research nurses, research coordinators, dietetic interns, new phlebotomists, medical residents and fellows.
The CCRC is located in the Cypress Building (2221 Stockton Blvd, Suite D), adjacent to the UC Davis Medical Center. This 3,500 square foot clinic space has four infusion chairs, a procedure room, two phlebotomy stations, two examination rooms, two interview rooms and a room with a hospital bed. This clinic is designed to meet a variety of outpatient research needs. Additionally, there is a laboratory processing room with a centrifuge and -80° Celsius freezer, an exercise laboratory with a DXA machine, EKG stress treadmill and bike system, and a metabolic cart. Plenty of workspace is available for investigators and coordinators to use during their patients’ appointments. Visit our map and parking page for more information.
It is important to include appropriate fees in your budget to ensure adequate resources are available for CCRC support. For current fees please contact Nicole Hansen at firstname.lastname@example.org.
Boilerplate Text for Budget Justification
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.
Who is eligible to use the CCRC?
The CCRC is available to UC Davis faculty, residents, postgraduate fellows, medical students, and nurses with an IRB-approved protocol.
What CCRC resources are available?
Outpatient and inpatient nursing support, bionutrition, exercise physiology, regulatory, and laboratory services are available to investigators. Nursing services include investigational drug administration, serial blood sampling, monitoring, invasive procedure assistance, EKG or cardiac monitoring, and qualitative data collection. A nurse practitioner is on-site to provide additional services to investigators, such as history and physical exams, invasive procedures (i.e., biopsies), and bedside monitoring during high risk infusions. A research dietitian is available to assist investigators with nutrition requirements, food intake analysis, or participant education. Our exercise physiologist is available to measure body composition, metabolic rate, bone density, other unique exercise-fitness testing, and participant education. A laboratory technician can assist with unique laboratory testing or processing needs.
Services can be provided at the CCRC, the UC Davis Medical Center, other Health System locations, the UC Davis Campus, in patients’ homes, or at most other community-based locations.
What kind of research can the CCRC support?
The CCRC supports human-based, multi-disciplinary clinical research. Participants may be healthy controls or diagnosed with an acute or chronic condition. We currently support studies from the following departments: internal medicine; internal medicine subspecialties, such as oncology, neurology, cardiology; surgery; radiology; epidemiology; obstetrics and gynecology; psychiatry; pediatrics; and nursing.
Are non-M.D.s allowed to conduct studies at the CCRC?
Yes. Non-M.D. investigators, such as Pharm.D.s and Ph.D.s, may request our services.
What if there are revisions to the original approved protocol or consent?
All protocol modifications and renewals, once approved by the IRB, should be forwarded to the CCRC coordinator so that we can ensure protocol compliance.
Does the CCRC have funds for ancillary testing?
No. The CCRC does not have funds to cover ancillary testing performed in departments, such as pathology or radiology. The CCRC can assist investigators with the coordination for ancillary support throughout the UC Davis Health System.
What type of financial support is required to conduct a study at the CCRC?
The CCRC can support investigator-initiated (department or grant-funded) and industry-sponsored research. It is important to get an estimate for these services when you are planning your budget.
What services are offered at the CCRC?
All services are tailored to investigator and protocol needs. A list of standard services provided by the CCRC is found in the CCRC Service Catalog
Is there a fee for using these services?
Yes. For current fees please email Nicole Hansen at email@example.com.
You will need to include estimated fees in your budget prior to approval of CCRC support. Any questions about this rate or its justification should be directed to Nicole Hansen at firstname.lastname@example.org.
How do I access the services of the CCRC?
Simply complete an online Service Request Application.
How are research participants scheduled?
Appointments are made via a fax scheduling process. This process will be reviewed with you during a “Start Up” meeting after your Service Request has been approved.
If you still have questions, please contact the Nurse Manager, Nicole Hansen at email@example.com.