GCRC Resources

I would like to highlight a number of features of the UNC General Clinical Research Center (GCRC). The Verne S. Caviness General Clinical Research Center is now in its 43rd year of continuous NIH support. It is a fully self-contained inpatient and outpatient research facility, centrally located on the third flood of the Main Bedtower wing of UNC Hospitals. In addition to the in- and outpatient facilities, the GCRC area consists of a Core laboratory, a Metabolic Kitchen, a Body Composition Laboratory, a Computer center, conference room and office space for the Program Director, Assistant Program Director, Bioinformatics Core, Biostatistician and Epidemiologist, Directors of Nursing, Bionutrition Core and Body Composition Laboratory, the Research Subjects Advocates, the Professional Development Coordinator and GCRC trainees.

The inpatient wing of the GCRC is comprised of 10 private patient rooms. The nurses' station, specimen handling room, dirty utility room, clean utility room, weight and height room, tub and shower rooms, and a treatment room are also present in the inpatient area. The outpatient area includes a reception desk and nurses’ station, waiting room and outpatient examination and infusion rooms, dining area, and a phlebotomy area. The Bionutrition Core is also located on this wing and includes a fully equipped Metabolic Kitchen, and a Body Composition Laboratory staffed by three Research Nutritionists, a Certified Dietary Manager, five Dietetic Technicians, and a Body Composition Laboratory Technician.

The Center is operated by a dedicated and thoroughly professional staff of individuals, all of whom are committed to ensuring the safe and effective conduct of all types of human investigation. The GCRC nurses, the staff of the metabolic kitchen, the computer system manager, the biostatistician, the clinical epidemiologist, the research subject advocates and the program directors work as a team to ensure that each aspect of clinical investigation from the design of the study, to the conduct of the research, to the analysis of the data is carried out with utmost care and attention to every detail.

The nursing staff are trained in sophisticated research procedures. Members of the nursing staff have a cross section of clinical experience including: Emergency Department, Intensive Care Unit, Oncology, Medical/Surgery, and Pediatrics. Several nurses have completed advanced certificates in oncology and cardiology. In addition, they are available to assist with obtaining biological specimens (blood and urine) and processing of these specimens in the laboratory.

The Bionutrition Core consists of a metabolic kitchen, a body composition laboratory, and a staff of Research Dietitians trained in nutrition research procedures. The GCRC Research Kitchen is 475 square feet in size and is designed for the formulation and preparation of foods for nutrition research diets. It is staffed with 6 full-time personnel who are experienced in research diet methodology. Foods are purchased and prepared for clinical studies by the staff in the GCRC. The Research Nutritionists supervise the calculation and preparation of all research diets, perform nutrition measurements on patients, and assist investigators with development of research methods and research proposals.

The Body Composition Laboratory includes a metabolic cart, a Hologic Delphi W DXA, an Orthometrix peripheral QCT, accelerometers, and bioelectric impedance analysis equipment. This laboratory is staffed by a full-time medical technologist who has been trained in each of these specialized measurements.

The Clinical Research Center Informatics Core has a Local Area Network which includes approximately 45 personal computers with centralized NT and UNIX servers providing file, database, and web services all of which is under the supervision of a computer systems manager. This facility is available for data management and analysis. There is wide connectivity throughout the School of Medicine Information Network (SOMIN) to the GCRC computing resources and programs, such as SAS and the SQL database server. The GCRC is connected by fiber optic cable to the School of Medicine and from there to main campus, the commercial Internet, and Internet-2.

The BioInformatics core also provides a consultation service that includes both a biostatistician and an epidemiologist. Both of these individuals are faculty members in our internationally recognized School of Public Health, and each has regular office hours on the GCRC.

The Research Subject Advocate Office provides oversight of all GCRC protocols from the perspective of subject safety. The office employs a physician and a Registered Nurse with many years of experience in clinical research. They provide guidance to investigators in formulating safety monitoring plans that are required for all GCRC studies. They also conduct quality assurance reviews of investigator initiated GCRc protocols.

The Office of Training and Career Development is directed by Susan Pusek, MPH, who has over 10 years experience with all aspects of clinical trials at our institution. She helps junior faculty, or other individuals beginning clinical research, navigate the process of protocol development, IRB and GCRC approval, IND submissions, record keeping and adherence to Good Clinical Practices.

The Bioanalytical Core Laboratory (BAC) in the UNC General Clinical Research Center is a dedicated laboratory space fully equipped to obtain, process, aliquot, freeze and store blood and tissue specimens. The laboratory facilities include centrifugation equipment as well as refrigerators and freezers at 0 and -70 degrees Fahrenheit. Routine laboratory analyses are performed in the hospital laboratory under a cooperative agreement with the General Clinical Research Center. Highly specialized laboratory analyses are performed in the Core Laboratory. Of particular note are the catacholamine and bendorphine determinations, which are run on a daily basis for numerous GCRC investigators. In addition, our BAC lab has a special arrangement with Dr. Steven Offenbacher (Dental Research Center) to provide ELISA measurements of a variety of inflammatory mediators including many cytokines.

The Investigational Drug Service (IDS) provides pharmacy support for clinical research studies. The IDS is a division of UNC Hospitals Department of Pharmacy and is located in dedicated space adjacent to the GCRC. The IDS was originally established in 1982, its purpose being to assure the safe use of investigational drugs and to make certain that UNC investigators are in full compliance with all laws and regulations applicable to clinical drug research. The pharmacy is fully staffed and is available to assist investigators with the planning, initiation, and implementation of investigational drug protocols, and to serve as a central site for the receipt, storage, distribution, and accounting of research pharmaceuticals. Twenty-four hour on-call service by an IDS pharmacist is available to address any problems that may develop during the course of an IDS-supported study.

With these facilities more than 200 active clinical research protocols are supported annually. These research protocols are conducted by investigators from departments in the Schools of Medicine, Nursing, Pharmacy, and Public Health.