The mission of the General Clinical Research Center (GCRC) is to facilitate and enhance the performance of patient-oriented research to help understand human physiology, translate basic research into patient care, and develop new therapies. The GCRC accomplishes these goals by providing core support for the design, implementation, and analysis of clinical studies. This includes inpatient and outpatient research space, the expertise of well-trained research nurses, and dietary, core laboratory, biostatistical, and informatics support. The GCRC is also committed to creating an environment that ensures the training of the next generation of clinical investigators.

Overview

The GCRC at Northwestern University's Feinberg School of Medicine has been an active and vital research facility within the Northwestern community for more than forty years. Investigators conducting clinical research studies at the Feinberg School of Medicine, Northwestern Memorial Hospital (NMH), and Children's Memorial Hospital (CMH) may choose to work with the support of the GCRC. The primary facility for the GCRC is a discrete unit located on the 10th floor of NMH's Feinberg Pavilion.

The GCRC at Northwestern is one of approximately eighty centers located in major academic medical centers across the nation that are supported by the National Institutes of Health (NIH), National Center for Research Resources (NCRR).

Authorized by Congress in 1959, the national GCRC program is dedicated to providing the infrastructure and resources needed to support patient-oriented clinical research. Research conducted at the GCRC may contribute to advances in the understanding of pathophysiology, disease diagnosis and progression, the evaluation of new therapies, and the development of new and improved methods of health care.

Designed for the conduct of safe, state-of-the-art clinical research in a supportive environment that cultivates the highest clinical and ethical standards, the GCRC encourages translational and collaborative research. Investigators with funding from the National Institutes of Health, other federal or state agencies, foundations or private endowments, or industry sources may apply to use the GCRC. The center's resources may also be requested to support pilot studies with the goal of obtaining preliminary data for further research.

The Northwestern University GCRC offers several core resource facilities. These primary core resources are available as direct support to approved investigator-initiated, peer-reviewed studies carried out at the GCRC. The services are also available at minimal, cost-recovery-based charges for industry-sponsored studies.

At NMH, the discrete unit features six inpatient beds and a 1,334 square foot outpatient facility with four outpatient rooms and five outpatient beds. The facility's environment can be adapted for specific study requirements, such as sleep studies or bone marrow transplant.

A core laboratory provides a range of assays, specimen processing, and storage services. There is also a research dietary core offering dietary services, testing, and measurements such as basal metabolism, resting energy expenditure, and body mass index by multifrequency bioimpedance analysis. The dietary facility includes a research kitchen for the formulation of special or controlled diets and dietary analysis.

GCRC nursing personnel are specialists trained for research procedures, including, but not limited to, pharmacokinetic studies, circadian studies, oral glucose tolerance tests, tilt table research, continuous pulse and blood pressure monitoring, EKGs, pituitary hormone testing, central line access and site care, CADD pump infusion, chemotherapy administration, monoclonal antibody administration, and adverse event management. A biostatistician is available to provide biostatistical support to GCRC investigators.

For studies involving pediatric participants, outpatient services and inpatient beds are available at CMH, and specimens may be transported to NMH for core laboratory processing and assays.

Investigators in many diverse areas of research use the services of the GCRC. In 2001 there were fifty-seven active clinical research protocols from fourteen medical school departments and divisions. During that year, there were more than 950 inpatient research days and close to 3,000 outpatient research visits. The Scientific Advisory Committee (SAC) reviews all GCRC protocol application submissions for scientific merit and utilization of GCRC services. The SAC also sets priorities and reviews policies for the center. All protocols must receive full Institutional Review Board approval before they are initiated at the GCRC.