New
Clinical Trials Center provides range of research support services
A new clinical research service center was recently launched at MUSC
to support investigators who wish to initiate or expand corporate-sponsored
clinical trials. The new Clinical Trials Center is designed to provide
research coordination and ancillary services on a fee basis. By relieving
investigators of the need to make long-term commitments to personnel
and individually negotiate required services, the Clinical Trials Center
(CTC) will increase efficiencies and cost-effectiveness for the investigators
who do not wish or need to create the entire infrastructure necessary
to conduct clinical studies.
Located on the 2nd floor of the Clinical Sciences Building in Suite
214, CTC is adjacent to MUSC’s General Clinical Research Center
(GCRC), which is designed to support NIH and other peer-review sponsored
clinical studies. Facilities include outpatient exam rooms, phlebotomy
area, a physiology lab with impedance cardiology and spectral analysis
capabilities, procedure rooms, and conference facilities. The proximity
and parallel purposes of the GCRC and CTC promote optimal resource allocation
and utilization. Dr. Peter Wilson, Professor of Medicine, directs both
activities, with assistance from Vickie Wickman, GCRC Administrator,
and Lynne Hartel, CTC Coordinator.
The CTC mission is “to enable the performance of clinical research
by providing investigators with optimal support for designing, initiating,
completing and reporting data from patient based investigation.”
Study initiation services include: IRB submission and follow-up, assistance
with protocol review and budget preparation, and completion and submission
of all sponsor regulatory documents. Study coordination services include:
subject recruitment and scheduling, informed consent, data acquisition,
completion of case report forms, submission of protocol deviations,
adverse event reporting, data entry and report, and close-out procedures.
Study monitoring services are also available.
Ancillary services include nursing resources, clinical and molecular
laboratory resources, nutritional resources, bone densitometry, and
echocardiography. Charges for services are calculated on the number
of subjects, subject visits, clinical services required, study phase,
and length of study.
For more information, visit www.ctc.musc.edu,
or contact Lynne Hartel at 792-8385.