General Clinical Research Center
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General Clinical Research Center
Providing Infrastructure for Research
Since 1961, the General Clinical Research Center (GCRC) at the Medical College of Wisconsin has provided a setting for faculty members to conduct patient-oriented research. The center is one of 78 GCRCs in the United States supported by a grant from the National Center for Research Resources of the National Institutes of Health. The GCRCs are a national network of centers for medical investigators to conduct safe, controlled, inpatient and outpatient studies of children and adults.
The Medical College of Wisconsin GCRC is one of the first NIH-sponsored GCRC sites. The GCRC includes an Adult Center (age 18 and older) in the Lower Level Pavilion at Froedtert Hospital. This site, for inpatient and outpatient studies, has three study suites and five outpatient exam rooms. In addition, an outpatient Pediatric Unit Satellite is based at Children’s Hospital of Wisconsin (age 17 and younger).
In 2005, the center recorded 4,783 patient visits. Currently, investigators are conducting more than 100 active research protocols. Major areas of investigation are cardiovascular diseases, endocrinology and metabolism, gastroenterology, gerontology, hematology, nephrology, neurology, oncology, pediatrics, pulmonary diseases and women’s health.
Investigators are required to be Medical College of Wisconsin faculty members. Non-faculty members, such as referring physicians, may align with a faculty member to have their patients participate in a study. The GCRC can be used by investigators who are supported by the NIH as well as investigators who are supported by funds provided by other federal, state and local agencies, and the private sector.
“The difference between the GCRC and industry-sponsored clinical trials is that we’re doing investigator initiated research here,” said Linda Templin, RN, Nursing Supervisor at the GCRC. “The center provides an infrastructure for new investigators and for those who are under-funded. Our staff can help investigators in developing their protocols and gathering the support they need to conduct their studies.”
To initiate a study, the principal investigator — a physician or a PhD — submits a research protocol to the GCRC for consideration. The multi-disciplinary GCRC Review Committee reviews the protocol before sending it to the appropriate hospital’s Institutional Review Board (IRB).
Research Participants must sign an informed consent form to participate in all GCRC studies. A research subject advocate is on the GCRC staff to ensure that studies are designed and conducted safely and ethically and that participants understand the study in which they are participating.
GCRC resources for investigators include:
- A Bioinformatics core to assist investigators in large-scale data projects
- A Bionutrition core to help plan and conduct the nutritional component of protocols
- Biostatistical consultation for issues such as power calculations, sample sizes and stratifications to ensure statistical validity
- A core laboratory to process and store samples, and assist investigators with non-routine reproducible and reliable analytical procedures
- An Imaging Core to understand brain systems activated when study participants perform sensory, motor and cognitive tasks in the MRI scanner (the center was the first in the country to use Functional Magnetic Resonance Imaging (fMRI)
- An Informatics core with Macintosh and PC-based hardware and software, data backup and safe storage, along with expert consultation on establishing and maintaining databases
- Training through the GCRC and the Medical College of Wisconsin
- Nursing support to provide high-quality nursing care to research patients, guided by IRB approved research protocols and NIH guidelines
- Ancillary support services
To learn more about the GCRC at the Medical College of Wisconsin, call the Access Center at 414-805-3666 or 800-272-3666.
Author: Marla Fraunfelder Date: May 2006 Online Editor(s): Christopher Sadler |
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