Needs identified by the research community at MUSC and changes in NIH funding mechanisms have led to significant changes in operations of the Research Support Center at MUSC. This Center, located on the 2nd floor Clinical Science Building, offers two programs to support clinical research. The General Clinical Research Center (GCRC) is funded by the NIH to support "investigator-initiated" clinical research and can fund most clinical services needed by the investigator if these services are not funded through other sources. The Clinical Trials Center (CTC) supports "industry-initiated" research. Services provided through the CTC are funded by the industry sponsor and charged to the investigator on a "procedural" basis. By centralizing the two programs in one location and sharing staff between the programs, service quality and research compliance can be assured as well as providing services in the most cost effective manner for MUSC and its investigators and sponsors.

A significant decline in the need for inpatient research days led to the closure of the inpatient research unit, located on 6 Center MUHA. This closure is being phased in by July 2004. Throughout the US, NIH funding for centralized inpatient research units is being replaced with funding for inpatient care on a "per diem" basis. This means investigators who initiate their own research protocols will now be able to admit subjects to a variety of inpatient units in the Medical University Hospital, thus affording their subjects the required specialized care. The GCRC is awarded NIH funds to pay for these inpatient days as long as the research requests are submitted and approved for implementation through the GCRC. Routine inpatient care will be provided by MUHA nursing staff, and GCRC staff will provide research care. Industry-sponsored studies may also admit subjects for inpatient care; however, the investigator will be billed for inpatient days.

In concert with the July closure of the inpatient unit, the outpatient center plans to expand hours of operation. The 9,000 square foot Research Support Center, located on the 2nd floor Clinical Science Building, provides eight examination rooms, three procedure rooms, a dental suite, bone imaging suite, core laboratory for clinical and molecular lab analysis, research kitchen and computer support area. Services are currently available from 7:00 a.m. to 4:00 p.m. with plans to extend hours to accommodate longer studies up to 16 hours as this need develops. Some subjects may benefit by being admitted to the short stay unit for overnight control of variables, and then receive research care in the outpatient research clinic during the day.

Funding Support
"Investigator-initiated" research approved by the GCRC Advisory Committee may receive funding support for inpatient days, outpatient visits, nursing services, clinical and molecular lab analyses, bone imaging, EKG’s, echocardiograhpy, nutritional services, spirometry, dental services and other ancillary services provided at MUHA. In addition to these clinical services, the GCRC is funded to provide biostatistical support and Informatics support to assist in the research design, data collection and analysis phase of your research. To receive this support, research protocols are submitted to the GCRC Advisory Committee who reviews and allocates support service funding based on scientific merit of the research and current funds available from the NIH National Center for Research Resources. The investigator's other sources of funding are reviewed and decisions of support are based on needs. The GCRC cannot fund services funded through other sources. Investigators are advised to consult with the GCRC office prior to developing study budgets in order to coordinate funding sources.

Professional staff support Registered Nurses and Medical Technicians who have been specially trained and certified in research methods and compliance as required by the NIH Office for the Protection from Research Risks (OPRR) provide clinical nursing services. The staff collects complex physical assessment data, performs EKGs and spirometry, provides phlebotomy services and administers medications and IV infusions. The nursing staff is certified in BLS, chemotherapy administration and diabetes education.

Clinical and molecular lab analyses are performed either in the core laboratory or processed and sent to the MUHA clinical laboratory for routine analyses. Specimens can be processed and shipped to central laboratories for industry-sponsored clinical trials. Molecular services are under the direction of a molecular biologist with the support of a medical lab technologist and research technician. The laboratory provides services such as EBV-transformation, DNA/RNA extraction, DHPLC, and DNA sequencing for gene mutation analysis. To satisfy the needs of investigators, the laboratory has developed non-routine assays that are not available from the MUHA clinical laboratory. In addition, the molecular core laboratory has provided investigators with advice and/or hands-on training in molecular techniques.

Bone Imaging services are provided using a Hologic 4500 DEXAscanner and a new Discovery model with infant software. An Imaging technician is available to provide infant and adult bone densitometry services using the latest technology for hip and spine bone density studies or total body composition studies.

The dental suite is the latest addition designed to support a variety of dental services from routine examinations and specimen collection to advanced Xray technology.

Nutritional services range from providing routine snacks and meal services to complex research diets. The goal of nutritional intervention is to decrease variability in the parameters being measured by having the ability to prepare the test meals of known nutrient contents. Research nutritionists provide complex nutrient analyses using state of the art nutritional analysis software, perform anthropometric measurements and provide dietary education and consultation.

The Biostatistician consults with investigators to review sample size requirements, appropriate statistical methodology, and study design prior to and following protocol submission to reviewing agencies. He/she may also assist in drafting the statistical section of a manuscript intended for publication in a refereed journal. Consultations on the inclusion of genetics and referrals to statisticians or epidemiologists who can serve as collaborators on grant applications are also valuable services provided by the biostatistician.

Computer/Informatics support services are available to assure that research data are collected accurately, monitored appropriately, managed effectively, and accessible for analysis and reporting. Open DataBase Connectivity (ODBC) allows direct access to the databases to run statistics, eliminating time-consuming export of data. Security is assured by the use of a "protected" web-based database for data input, manipulation, and reporting. All systems are backed up daily.

Research Coordination
Research coordinator services are available for both "investigator-initiated" and "industry-initiated" clinical trials. These services include assistance with budget preparation, regulatory documents, IRB applications, subject screening and enrollment services and scheduling clinical services. The Research Coordinator will also maintain subject/protocol records and all study supplies; file adverse event reports; and participate in sponsor’s monitor visits and audits. The clinic setting of examination rooms, phlebotomy area, procedure rooms and laboratory services offers efficient scheduling for study patients and Investigators. These services are provided for fees negotiated with the investigator. Fees are based on the number of subjects, study visits, clinical services needed, and length of the study.

Fees and Applying for Support
Further information, fee schedules and information on applying for support is available at the following web sites:

"Investigator-Initiated" Research: http://www.gcrc.musc.edu
"Industry-Initiated" Research: http://www.ctc.musc.edu
Research Coordination: http://www.ctc.musc.edu