Protocol Categories

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.
 
NIH logo The UK GCRC is funded by National Center for Research Resources
National Institutes of Health     M01 RR02602