Administrative and Clinical Research Support Core

行政和临床研究支持核心将为所有行政部门提供必要的支持 与计划项目拨款相关的活动和临床试验。广泛的早期临床试验 本续展申请范围内项目1-3的活动要求核心开展更多的活动。 核心的行政部门将为会计、预算编制、财务报告和 通信，而临床研究支持部分将促进方案的激活和执行， 在项目与核心B(生物统计)和核心C(免疫)之间有效传播信息 监测和组织分析)。临床研究支持活动将包括准备和分发 方案修订、研究样本日历监测、收集、跟踪和分发到研究 实验室地点，以及监测集中采购材料的供应采购和分配 临床试验所需。核心A人员还将确保适当的准备和及时提交 明尼苏达大学癌症中心机构审查委员会(IRB)需要审查的方案 议定书审查委员会、食品和药物管理局和国家骨髓捐赠者计划 (NMDP)IRB。核心人员将为其他临床现场调查人员提供所有必要的信息 准备提交给自己的机构审查委员会和其他内部和外部监管机构。 在即将到来的资金期，Core A还将更直接地参与确保高质量的业绩 项目1-3中拟议试验所需的礼宾活动。核心职责将包括协议 定期通过面对面会议监督项目和核心人员之间的沟通 预定的电话会议，以及额外的电话通信。此外，核心将支持 安排和协调内部研究会议和外部顾问访问。最后，核心A将 继承目前NK细胞免疫遗传学基金的既定成果。核心人员将 通过NMDP和新的KIR等位基因和大分子的筛选来协调NK细胞产物的KIR/HLA配型 项目调查人员的移植队列分析，包括对第三方CMV+捐赠者进行筛查 适应性NK细胞研究。这一广泛合作的资源将在红细胞移植结局的免疫遗传分析中发挥作用 用于评估KIR/人类白细胞抗原相互作用对NK细胞生物学、临床结果和设计的影响。 货架上的NK细胞产品。这个核心将由杰弗里·米勒博士领导，他将直接与他的高管一起工作 委员会和外部咨询委员会协调他们在本计划中的参与。具体目标 核心是提供行政支持、科学监督、临床监督/服务、协调 HL A/KIR分型和分析，以及促进PPG互动和合作的领导力和资源。

The Administration and Clinical Research Support Core will provide essential support for all administrative activities and clinical trials associated with the program project grant. The extensive early phase clinical trial activities in Projects 1-3 within this renewal application has required expanded activities undertaken by the Core. The administrative components of the Core will provide support for accounting, budgeting, fiscal reporting, and communication, while the clinical research support components will facilitate protocol activation and execution, effective dissemination of information between Projects and Core B (biostatistics) and Core C (Immune Monitoring & Tissue Analysis). Clinical research support activities will include preparation and distribution of protocol revisions, research sample calendar monitoring, collection, tracking, and distribution to research laboratory sites, as well as monitoring supply procurement and distribution for centrally purchased materials needed for clinical trials. Core A personnel will also assure appropriate preparation and timely submission of protocols for review as needed by the University of Minnesota Institutional Review Board (IRB), Cancer Center Protocol Review Committee, the Food and Drug Administration, and the National Marrow Donor Program (NMDP) IRB. Core personnel will provide all necessary information for the other clinical site investigators to be prepared for submission to their own Institutional Review Board and other internal and external regulatory bodies. In the upcoming funding period, Core A will also assume more direct involvement in insuring quality performance of required protocol activities for the proposed trials in Projects 1-3. Core responsibilities will include protocol monitoring and communication among project and core personnel through in-person meetings, regularly scheduled conference calls, and additional telephone communication. Additionally, the Core will support scheduling and coordination of internal research meetings and external consultant visits. Finally, Core A will carry on the established accomplishments of the current funding in NK cell immunogenetics. Core personnel will coordinate KIR/HLA typing of NK cell products through the NMDP and curation of new KIR alleles and large transplant cohort analyses by Project investigators including the screening of third party CMV+ donors for adaptive NK cell studies. This broadly collaborative resource in immunogenetic analysis of HCT outcomes will be used to assess the impact of KIR/HLA interactions on NK cell biology, clinical outcomes, and design off-the- shelf NK cell products. This Core will be led by Dr. Jeffrey Miller who will work directly with his Executive Committee and External Advisory Board to coordinate their involvement within this Program. The Specific Aims of the Core are to provide administrative support, scientific oversight, clinical oversight/services, coordination of HLA/KIR typing and analysis, and leadership and resources to promote PPG interactions and collaborations.