Office for Research and Graduate Studies (ORAGS)

School of Medicine General Clinical Research Center (GCRC)

Scientific Objectives:  The University of Maryland General Clinical Research Center (GCRC) supports our mission to serve the medical needs of the people of Maryland and the region by providing comprehensive care for the community, tertiary care to the state and surrounding areas, and serving as the primary site for health education and research.  The GCRC serves as the primary location for NIH/NCRR funded inpatient and outpatient clinical research and training.

Research projects may include off site studies related to long-term care, preventive and interventional medical care. Participants may have a disease process or be normal volunteers, who serve as study subjects or controls, and whose ages may range from children to geriatric age groups. Participants may come from the local community or be recruited nationally or internationally. Participants may enroll in studies that include unproved forms of therapy or diagnostic techniques that may become future healthcare standards. GCRC services support clinical research activities and include nursing, dietary, laboratory, genomics core laboratory, data management, biostatistical and administrative support. Each service adheres to national practice standards and guidelines such as the Code of Federal Regulations & ICH Guidelines, JCAHO, American Nurses Association (ANA), NIH Guidelines for Clinical Research Centers Program (MO1) (November 2001), Recommendations for Patient Safety in Clinical Research (May 17, 2001), the University of Maryland Institutional Review Board for Human Subjects in Research (IRB), and General Clinical Research Center Advisory Committee (GAC) as well as the policies and procedures of the UMMC.

GCRC services are available 24 hours a day, seven days a week as dictated by the research protocols. Studies involve varying levels of complexity such as simple data collection or complex assessment of physiologic stability. Staff coordinates both non-invasive and invasive studies such as tissue biopsies and frequent blood sampling. Participants are provided instructions regarding their rights and responsibilities as research subjects and given information for protocol-specific procedures such as questionnaire completion, medication administration, diet records, return appointments, radiological and other medical procedures. Discharge instructions include medical follow-up for potential adverse experiences related to study drugs or invasive procedures. Nursing staffing patterns are determined by a nursing intensity and participant acuity rating scale.

Facilities:

Outpatient:

*           Four Outpatient Exam Rooms
*           Outpatient Area:
*           5 comfortable recliners with privacy curtains
*           5 phlebotomy chairs
*           Nursing station with computer workstation
*           DEXA (Duel Energy X-Ray Absorptiometry) Facility
*           Conference Room
*           Reception and Waiting Areas
*           Specimen Processing Laboratory with:
*           Countertop Refrigerated Centrifuge
*           Laminar Flow Hood
*           Refrigerator and –70 Freezer

Inpatient:

*           Six Inpatient Rooms (11 JCAHO approved beds), 24 hour nursing care
*           Kitchen/Activities Lounge
*           Stool Processing Room and Rehydration Station
*           Nursing station with computer workstation

Resources Available Through the GCRC:

            *           Genomics Core Facility 
                        O. Colin Stine, Ph.D.  6-1607 ostin001@umaryland.edu
                        Nick Ambulos, Ph.D.   6-8553 nambulos@umaryland.edu

            *           Bioinformatics Core
                        L. Samuel Dongmo, Ph.D.  8-8008  sdongmo@medicine.umaryland.edu

            *           Education and Training
                        Mary-Claire Roghmann, MD, MS  6-0062 

            *           Biostatistical Core
                        Patricia Langenberg, Ph.D.  6-3251  plangenb@umaryland.edu

                        Hegang Chen, Ph.D.   6-4067    hchen@epi.umaryland.edu
            *           Bionutrition Services

            *           Nursing Support for inpatient and outpatient data collection and patient care

            *           Resources to pay for ancillary laboratory testing

Contact Information:

Sharon Andres, GCRC Administrative Director  8-7368  sandres@medicine.umaryland.edu
Facility Location:
22 South Greene Street, 10^th floor, C and D wings
gcrc@medicine.umaryland.edu

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