Each protocol submitted to the GCRC
is assigned to one of four categories:
Investigator-initiated Research (Category
A)
All Investigator-initiated trials, designed by a single investigator
or a consortium of investigators, are classified as category A.
In some cases, a commercial organization may provide clinical research
funds for an investigator-initiated study. If investigator-initiated,
the research project is appropriately classified as Category A or Category
B rather than a Category D study
Research Service (Category B)
This category pertains to patients who require hospitalization
or outpatient studies for diagnosis or treatment according
to established standards
of care. The cost of established medical care is not charged
to a GCRC grant.
Industry-Initiated (Category D)
This category includes inpatient days or outpatient visits
utilized for an Industry-Initiated study. All charges
are paid by industry.
Non-Research (Category C)
Patients who are not participating in a research project
may be admitted to the GCRC solely for the purpose of
diagnosis or treatment according
to established procedures, only when there is space and
staffing available at the GCRC.
Assignments are made for each research project by the program director
and GCRC Advisory Committee (GAC), in consultation with
the involved investigator. The GAC evaluation of research
projects for GCRC use
is made exclusively on the basis
of the scientific merit of the projects and their need
for the GCRC assistance, without regard to the assigned
category.
The UK GCRC is funded by National Center for Research Resources
National Institutes of Health M01 RR02602