Biospecimen, Pathology, and Immune Monitoring

生物标本、病理学和免疫监测核心（核心D）将提供领导和专业知识， 需要支持临床前研究和与每项研究相关的预期临床试验 这四个项目构成了这个SPORE应用程序。《核心》由罗杰·麦克伦登博士共同执导， 肯特温霍尔德。McLendon博士将监督采购，准备，注释和沉积所有预- 从四个项目中的每一个项目收集临床和临床标本，并将其放入生物标本库。此外，博士。 McLendon将监督由特定研究决定的生物标本的指定病理分析 包括四个项目。他将直接与所有项目负责人以及指定的工作人员互动 关于核心D的持续支持。他将确保所有程序的执行符合 标准操作规程（SOP）以及临床实验室改进部制定的指南 修正案（CLIA），美国病理学家学院（CAP）和其他实体。Weinhold医生会监督 为每个SPORE项目提供临床前和临床免疫监测支持，并将 全权负责保证及时分析和尽可能高的数据质量。他将定期 直接与四个SPORE项目的项目负责人和工作人员互动， 保持项目与核心D之间的重要沟通渠道。伊丽莎白·里普博士，她的校长 职责将包括所有临床前免疫监测研究的执行以及指导 已建立的Inter-SPORE免疫监测联盟正在进行的活动将帮助他完成这些任务。 活动此外，协助Weinhold博士的还有Janet Staats女士，她将负责管理所有临床免疫治疗。 根据药物临床试验质量管理规范，使用已建立的SOP和正式验证的检测方法进行监测 实验室规范（GCLP）指南。

The Biospecimen, Pathology, and Immune Monitoring Core (Core D) will provide the leadership and expertise required to support both the pre-clinical studies and the anticipated clinical trials that are associated with each of the four Projects comprising this SPORE application. The Core is co-directed by Drs. Roger McLendon and Kent Weinhold. Dr. McLendon will oversee the procurement, preparation, annotation, and deposition of all pre- clinical and clinical specimens from each of the four Projects into the Biospecimen repository. Additionally, Dr. McLendon will oversee the designated pathologic analyses of biospecimens, dictated by the specific studies comprising each of the four Projects. He will interact directly with all Project Leaders as well as designated staff regarding ongoing support by Core D. He will assure that all procedures are performed in compliance with Standard Operating Procedures (SOPs) as well as guidelines established by Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), and other entities. Dr. Weinhold will oversee all aspects of the pre-clinical and clinical immune monitoring support for each of the SPORE Projects, and will be solely responsible for assurance of timely analyses and the highest possible data quality. He will regularly interact directly with Project Leaders and Staff of each of the four SPORE Projects in order to establish and maintain critical lines of communication between the Projects and Core D. Dr. Elizabeth Reap, whose principal responsibilities will include the performance of all pre-clinical immune monitoring studies as well as directing the ongoing activities of the established Inter-SPORE Immune Monitoring Consortium, will assist him in these activities. Also assisting Dr. Weinhold will be Ms. Janet Staats who will manage all of the clinical immune monitoring efforts utilizing established SOPs and formally validated assays in compliance with Good Clinical Laboratory Practices (GCLP) guidelines.