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The NICHD Traumatic Brain
Injury Clinical Trials (TBI-CT) Network consists of
a team of academic clinical centers and a data coordinating
center, as well as the National Center for Medical Rehabilitation
Research at the National Institute of Child Health and Human
Development. The eight clinical centers: Temple University,
University of Alabama at Birmingham, University of Pittsburgh,
University of Washington and Virginia Commonwealth University,
University of Maryland School of Medicine, University of Tennessee
Health Science Center, University of Texas-Southwestern Medical
Center (as of March 2003), have agreed to investigate problems
in Traumatic Brain Injury in a collaborative manner. The clinical
centers represent premier institutions in TBI
medicine with track records of excellence in clinical research.
The data coordinating center was selected on the basis of their
experience with the coordination of multi-center clinical trials,
and with proven expertise in study design, data management and
biostatistical analysis. The Data Coordinating Center (DCC)
for the Network is the Columbia University Department of Biostatistics.
There are many unique and complex challenges involved in designing,
implementing, and monitoring high quality multicenter research
initiatives. Research design and methodology, staff resources,
study participant retention, data collection and analysis, training
and research capacity building, quality control, fiscal accountability,
and cost-effectiveness are just a few of the hurdles involved
with a cooperative network. The cooperative agreement mechanism
provides an infrastructure by which multidisciplinary staff
can efficiently develop and implement multiple, complex, research
projects simultaneously and disseminate information and research
results.
Overall program management and stewardship responsibility for
review and oversight of the cooperative agreement resides with
the NICHD. However, additional governing bodies have been established
to provide in-depth scientific evaluation and support of the
program.
The TBI-CT Network is overseen by three governing bodies:
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Steering Committee;
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Data and Safety
Monitoring Committee (DSMC);and
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Advisory Board
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