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General Clinical Research Center
"Today's Research, Tomorrow's Cures" |
CME course offered on 01/24/2008 “Practitioner’s Guide to Children’s Exercise in Health and Disease”
CTSC Standardized Participant Session Training Video
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Speaker: Deborah A Cohen, MD, MPH Senior Natural Scientist at Rand Corporation. |
Contribution of Public Parks to Physical Activity |
Hewitt Hall Conference Room (Lunch Provided) |
"The National Institutes of Health established the General Clinical Research Centers in 1959 through a Congressional mandate and the first Clinical Research Centers were opened in 1960. Since that time the program has expanded to include a network of 82 Centers and numerous satellite facilities. These GCRCs, supported by the NCRR's Clinical Research area, provide the infrastructure that allows medical investigators to conduct safe, state-of-the-art, patient-oriented research.
The General Clinical Research Center (GCRC) at the University of California, Irvine (satellite to the GCRC at the University of California, San Diego) has been in operation and funded by the National Center for Research Resources since April 2000. The GCRC provides an optimal setting for controlled studies by both basic and clinical investigators, encourages bi-directional interaction among those involved in basic and clinical research in multidisciplinary areas for studies of both adults and children, provides an environment and resources for developing future physician-scientists in the clinical research arena and can accommodate a variety of technological and therapeutic studies to ensure the expeditious translation of scientific knowledge into effective patient care.
The General Clinical Research Center outpatient clinic at UCI opened Spring 2003 and consists of approximately 9,500 sq feet of space at the UCI main campus in Irvine, California. The physical Center includes:
- A participant waiting room, front office reception, nurses' station, five exam rooms, a fully-equipped procedure room, four consultation rooms, a phlebotomy room, administrative offices, medical records storage and a conference room.
- Two Specialized Human Performance Laboratories dedicated to the development of innovative human performance technology.
- A second GCRC Sample Preparation Laboratory handles service requests that include, but are not limited to, specimen aliquoting, reagent preparation, sample storage (short- and long-term), and sample packaging and shipment.
- Storage space is available to investigators to store study-specific supplies and a conference room is made available for study meetings.
- A laboratory housing computers and space for the GCRC Neuroimaging Core
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In addition to the physical assets, the Center provides the important infrastructure that allows medical investigators and basic scientists to conduct safe, state-of-the-art, patient-oriented research. Some of those infrastructure components are:
- The nursing staff at the UCI GCRC consists of a Nurse Manager, clinical nurses, and medical assistants. The Nurse Manager is responsible for the administrative organization of the GCRC nursing staff, training, patient care delivery, and interaction with the investigators to assure that research projects are carried out as approved by the IRB and the GCRC Advisory Committee. The nursing staff is trained to make complex research observations and perform precise collections of specimens while providing exemplary patient care.
- A clinical investigator must be able to publish his/her scientific findings. This requires that data be (1) collected accurately, (2) monitored appropriately, (3) secured, (4) managed effectively, and (5) accessible for analysis and reporting. The mission of the Informatics Systems Unit is to provide the information infrastructure necessary to accomplish this.
- The responsibilities of the GCRC Biostatistician include, but are not limited to, collaboration with investigators on study design, implementation, analysis, interpretation, and dissemination of results. Additionally, the UCI GCRC Biostatistician trains clinical researchers in the principals of study design and analysis.
The first General Clinical Research Center outpatient clinic at UCI consists of approximately 4500 square feet of space at the UCI Medical Center in Orange, California. The physical Center includes:
- A participant waiting room, front office reception, nurses' station, four exam rooms, a DEXA scanning room, administrative offices and a conference room.
- A 450-square foot Specialized Human Performance Laboratory in which protocols utilizing cardiovascular components measurement, electromyogram analysis, exercise testing, functional electrical stimulation, metabolic component measurements, muscle biology, muscle imaging, muscle mechanics, and pulmonary function testing can be carried out in a safe and efficient setting.
- A Bionutrition Research Unit capable of preparing study-specific meals and snacks for both inpatient and outpatients studies. Additionally, the Bionutrition Research Unit provides invaluable resources to investigators by facilitating body composition studies (e.g. skinfold measurements, waist-to-hip ratio, DEXA, and BMI), biochemical analysis (e.g. nitrogen balance, indirect calorimetry, protein turnover), and other services such as nutrition assessment, calorie count, food records and dietary instruction.
- The GCRC Sample Preparation Laboratory handles service requests that include, but are not limited to, specimen aliquoting, reagent preparation, sample storage (short- and long-term), and sample packaging and shipment.
- Additionally, two network-linked PCs are available to investigators for their use, storage space is available to investigators to store study-specific supplies, and a conference room is made available for study meetings.
Finally, the UCI General Clinical Research Center encourages and supports training of young investigators and investigators who are shifting their research focus. This is accomplished through:
- The “Mentored Medical Student Clinical Research Program” provides support for a medical student to take time off from medical school to engage in a mentored program of up to one year of supervised participation in clinical research, didactic coursework related to patient-oriented research, and/or acquisition of laboratory skills that can be applied to patient-oriented research efforts.
- Regular rotation on the GCRC by research fellows, house officers, and medical, nursing, and dietary students is encouraged. Each student or postdoctoral fellow participates in research at the UCI GCRC has a qualified mentor. This mentor, typically the principal investigator of the protocol on which the trainee is working, is responsible for the medical and scientific quality of the work performed by the trainee.
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