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GCRC Advisory Committee (GAC) The GAC is appointed by the Principal Investigator of he GCRC, on a rotating basis. It is composed of a cross-section of faculty members who are familiar with the broad range of the GCRC research activities. The GAC supervises and reviews all operations of the GCRC, its Core Laboratories, Informatics Core, and other components; sets general policies; delineates common needs of the GCRC investigators; establishes admission policies; and evaluates projects for GCRC use. Studies on the GCRC must have GAC approval. This approval must be obtained prior to initiation. The GAC prospectively prioritizes projects for GCRC use to assist the Program Director in allocating resources. In all cases, NIH-funded clinical research is given preference. The GAC is responsible for ensuring implementation of existing NIH policy on the inclusion of women, minorities, and children as study subjects and for approval of DSM plans for all GCRC protocols. In addition, the GAC shall determine if a protocol involves significant risk and, if so, will evaluate and approve the required Data and Safety Monitoring Board (DSMB). For appropriate classification of industry-related projects, the GAC may request additional materials. The GAC reviews copies of the research agreement between the investigator and industry, an itemized budget, and other relevant correspondence, detailing the drug or other therapeutics or devices supplied. The GAC periodically reviews all GCRC operations to ensure that GCRC resources are used for the most scientifically justified and relevant projects. The GAC oversees the GCRC budget.
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