The administrative core with key clinical investigators from each participating clinical site will compile and submit FDA and harmonized IRB applications for approval. Dr. Sevick will be responsible for making the technologies available and overseeing overall execution of the primary project;Dr. Marshall will oversee regulatory and compliance aspects, and Dr. Berger along with participating clinicians will ensure patient safety and proper clinical trial design. Figure 2 illustrates the overall structure of the NTR team with the primary focus on clinical application of technologies to nodal staging of melanoma and breast cancer in Nuclear Medicine, the Operating Room, and Pathology. Task Specific Projects #1-4 and all Cores are housed within the Division of Molecular Imaging, of which Dr. Sevick is Division Head. Efforts demarked by a dashed box represent leveraged contributions provided without cost to the NTR. The administrative core comprised of Drs. Sevick, Marshall, and Berger will oversee all aspects of the NTR project, including technology deployment, compliance, and patient care and safety. Breast Center faculty (Chang, Gutierrez), Nuclear Medicine faculty (Wendt), Surgery faculty (Bonefas) who have clinical privileges at BTGH will assume patient care responsibilities in their specialty areas. Faculty with clinical privileges at the MEDVAMC in surgery (Berger, Albo), nuclear medicine (Bhargava) and pathology (Ittmann) will also assume patient care responsibilities in their specialty area. The Dan L. Duncan Cancer Center Clinical Trials Support Unit will assist in compliance activities and conduct audits to ensure adequate safety safeguards are in place during clinical studies. Quality assurance for GLP-compliant studies will fall under the Administrative Core, as will Quality Control for manufacturing procedures.
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