Administrative Core

由各参与临床研究中心的关键临床研究者组成的管理核心将汇编和 提交FDA和协调IRB申请以供批准。赛维克博士将负责制作 技术可用，并监督主要项目的整体执行;马歇尔博士将监督 法规和合规方面，Berger博士沿着参与临床医生将确保患者安全 和适当的临床试验设计。 图2显示了NTR团队的总体结构，主要关注临床应用， 核医学中黑色素瘤和乳腺癌的淋巴结分期技术，手术室， 病理任务特定项目#1-4和所有核心均位于 而赛维克博士是部门主管以虚线框标出的努力代表杠杆捐款 免费提供给NTR。由塞维克博士、马歇尔博士和伯杰博士组成的行政核心将 监督NTR项目的各个方面，包括技术部署、合规性和患者护理， 安全为代价的乳腺中心教师（Chang，Gutierrez），核医学教师（Wendt），外科教师（Bonefas） 在BTGH拥有临床特权的人将承担其专业领域的患者护理责任。教师 在MEDVAMC拥有外科（Berger，Albo），核医学（Bhargava）和病理学的临床特权 （Ittmann）还将承担其专业领域的患者护理责任。丹湖邓肯癌症 中心临床试验支持部门将协助开展合规活动并进行稽查，以确保充分 在临床研究过程中有安全保障措施。GLP合规性研究的质量保证将下降 在行政核心下，生产程序的质量控制也将如此。

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.