CTSC Clinical Research Center (CCRC) FAQ
Who is eligible to use the CCRC resources?
CCRC resources are available to UC Davis and VA investigators, and students for human subject studies that have current UC Davis IRB and/or VA IRB approval.
What CCRC resources are available?
Outpatient and Inpatient nursing, bionutrition, exercise physiology, regulatory, and laboratory services are available to investigators. A broad range of 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 sight to provide additional services to investigators such as history and physicals, 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-fit testing, and participant education. A laboratory technician can assist with unique laboratory testing or processing needs.
Services can be provided at the CCRC at the VA Medical Center, the CCRC satellite at TICON, or at any Health System or VA site, in subjects’ homes, or at most any other community-based location.
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-MDs allowed to conduct studies at the CCRC?
Yes. However, all non-MD investigators such as PharmDs and PhDs must have an MD co-investigator who will assume medical responsibility for the research participants.
What if there are revisions to the original approved protocol or consent?
All protocol modifications and renewals, once approved, should be forwarded to the CCRC coordinator so that we can ensure protocol compliance.
Who obtains informed consent of the research participant?
It is the responsibility of the principal investigator or appropriate designee to obtain informed consent from the research participant prior to the commencement of a study. Exceptions to this policy should be requested to Nicole Mullen, RN.
How is medical care provided on the CCRC unit?
The physician investigator, or physician for the study, is responsible for the medical care of research participants. The CCRC has a Medical Director and a Nurse Practitioner who is available to provide pre-arranged, additional, but limited coverage.
Does the CCRC have funds for ancillary testing?
No. The CCRC does not have funds to cover ancillary testing performed in departments such as clinical laboratory testing or radiology. The CCRC can assist investigators with the coordination for ancillary support through the VA and UCD.
Can I conduct an industry-supported study in the CCRC?
Yes. The CCRC supports both investigator-initiated and industry-sponsored research.
What services are offered at the CCRC?
All services are based on investigator and protocol needs. The following are some of the services:
- Adult Nurse Practitioner
- Body Composition Measurement: Anthropometric Measurements
- Body Composition Measurement: Bioelectrical Impedance Analysis (BIA)
- Body Composition Measurement: Bod Pod
- Body Composition Measurement: DEXA
- Cardiac Catheterization and invasive cardiac monitoring
- Cardiac Monitoring
- Catheter Access (Groshong, Port-a-Cath, PICC, & Hickman)
- Clinical Specimen Processing, Storage & Shipping
- Consultation on Body Composition & Energy Expenditure
- Consultation with Bionutritionist on Protocol Design, Methodology, & Data Analysis
- DNA & RNA Extraction & Purification
- Electrocardiograph (12-Lead ECG)
- Energy Expenditure & Body Composition: Training on Equipment and Procedures
- Energy Expenditure: Activity Monitoring
- Energy Expenditure: Exercise Testing
- Energy Expenditure: Indirect Calorimetry
- Experimental Design & Laboratory Expertise Consultation
- Feeding Studies
- Food Intake & Supplement Assessment
- Functional Genomics Consultation: Microarray Proteomics
- Genetic Analyses
- Identifying Academic, Community & Government Collaborators
- Inpatient Room
- Insulin Clamp
- Investigational New Drug (IND) & Investigational Device Exemption (IDE) Applications and Maintenance
- IV Starts & Medication Infusions
- IVGTT: Intravenous Glucose Tolerance Testing
- Laboratory Assays & Analyses
- Laboratory Equipment
- Lumbar Puncture Assistance
- Meal Tolerance Testing (MTT)
- Meals for Study Participants
- Nutrition Education & Counseling
- Oral Glucose Tolerance Testing
- Pediatric Nurse Practitioner
- Pediatric Nursing Services
- Pediatric Study Coordination
- Pharmacokinetic & Pharmacodynamic Studies
- Phlebotomy & Specimen Collection
- Point of Care Testing: CBG, Hemoglobin, HCG, & Urine Dip
- Research Meals & Diets
- Vital Signs & Physical Measurements
Is there a fee for using these services?
Yes. The UCDHS Rate Committee has established an outpatient rate of $78/hr for all CCRC services. The inpatient rate is $936/night. Rates are waived for students and scholars. You will need to include these fees in your budget prior to AFRU approval. Any questions about this rate or its justification, should be directed to the Nurse Manager or the Finance Manager.
For your budget justification, please use the following text:
The CTSC Clinical Research Center (CCRC) is a highly specialized patient unit that provides medical scientists with opportunities for careful study of disease. These facilities are governed by the National Center for Research Resources (NCRR), a center of the National Institutes of Health (NIH) under the Clinical and Translational Science Award program. They provide 10 RNs who provide 24/7 care to subjects enrolled in clinical research studies, a nurse practitioner who provides expanded services to investigators (i.e., clinical procedures, exams), an exercise physiologist who has a variety of methods of measuring body composition, bone density, metabolic rate and exercise fit through the use of a BOD POD, DEXA machine, Metabolic Cart, and 12 Lead EKG Stress Treadmill system; a research dietitian who provides nutritional support to study protocols by providing nutritional analysis, designing specialized meal plans, providing nutritional counseling to subjects, and on-site food preparation and lap support.
How do I access services to the CCRC?
Simply complete an online application for use of our resources (AFRU) by clicking on the button under the left navigation bar.
How are research participants scheduled?
Appointments are made via a fax scheduling process. This process will be reviewed with you after your AFRU application has been approved and during a “Start Up” meeting.
If you still have questions, please contact the Nurse Manager, Nicole Hansen