Administrative Core

项目摘要 美国国家老龄研究所（NIA）阿尔茨海默病（AD）和AD相关痴呆（AD/ADRD） 合作实验室将作为国家资源，促进嵌入式务实的发展和进行 临床试验（ePCT），以改善痴呆症患者（PWD）及其护理人员的护理和结果， 与提供护理的各种医疗保健系统（HCS）合作。为了实现这一目标， 合作必须不仅仅是各部分的总和。这种规模的倡议不仅要求每个国家 该组成部分拥有必要的基础设施和资源，而且活动是协同整合的， 跨组件。要做到这一点，需要一个特殊的行政和管理核心。该芯体的 具体目标是：目标1。管理和集成AD/ADRD的所有组件 合作;目标2.协调对试点项目的支持和指导，并协调国家情报局资助的调查人员开展 工作小组核心及行政小组的残疾人士ePCT;以及目标3。协调 开发和传播所有产品、指导材料和培训机会 在PWD及其护理人员中开展ePCT。有几个因素将使核心能够完成其艰巨的任务。 首先，它将受益于多个主要研究者（MPI）的经验丰富和有凝聚力的领导， Drs. Vincent莫尔（布朗大学公共卫生学院）和Susan Mitchell（希伯来高级生活研究所） 老化研究（HSL IFAR））。二是将行政责任的丰富研究作为支撑 这些机构的基础设施有着悠久的合作历史。两名高水平的执行官 董事将领导每个地点的团队; Rosa Baier MPH（Brown）和Ellen McCarthy PhD（HSL IFAR）。第三、 行政职能将由八个小组（每个地点四个）组成，具体如下：1.赠款管理 （布朗）; 2.组织和后勤（布朗）; 3。机构审查委员会（IRB）/法规（Brown），4.数据 分享和标准（布朗），5。研究者导航（HSL IFAR），6。交流和知识 传播（HSL IFAR），7。利益相关者参与（HSL IFAR），以及8。多样性和包容性（HSL IFAR）。 最后，专业服务提供商将参与管理可以完成更多的大型关键任务 利用他们的专业知识（例如网站创建和维护，单一的机构审查委员会（sIRB））。 核心小组特别具有创新性的职能包括：组织积极主动的项目支助， 强制性的sIRB，托管一个通用的REDCap数据库，以及一个专门的团队，以确保与 在ePCT设计的各个方面都满足多样性和包容性。影响：拟议的AD/ADRD合作实验室 拥有成功的所有必要因素：强有力的领导，充足的资源，专家领导的工作 集团核心和团队，以及具有高度影响力的议程。然而，所有这些要素都必须得到支持， 整合协作实验室，以改变残疾人护理的交付、质量和结果， 照顾者行政和管理核心在实现这一目标方面发挥着关键作用。

PROJECT SUMMARY The National Institute on Aging (NIA) Alzheimer's disease (AD) and AD-related dementia (AD/ADRD) Collaboratory will serve as a national resource to promote the development and conduct of embedded pragmatic clinical trials (ePCTs) to improve care and outcomes for persons with dementia (PWD) and their caregivers, in partnership with the various healthcare systems (HCS) that deliver their care. To achieve this objective, the Collaboratory must be more than just a sum of its parts. An initiative of this scope requires not only that each component has the requisite infrastructure and resources, but also that activities are synergistically integrated across components. To do so will require an exceptional Administration and Management Core. The Core’s Specific Aims are to: Aim 1. Administer, manage, and integrate all the components of the AD/ADRD Collaboratory; Aim 2. Coordinate support and guidance for pilot project and NIA-funded investigators conducting ePCTs in PWD from the Working Group Cores and Administration Teams; and Aim 3. Coordinate the development and dissemination of all products, guidance materials, and training opportunities for key aspects of conducting ePCTs in PWD and their caregivers. Several factors will enable the Core to meet its formidable task. First, it will benefit from the experienced and cohesive leadership of the Multiple Principal Investigators (MPIs), Drs. Vincent Mor (Brown University School of Public Health) and Susan Mitchell (Hebrew Senior Life Institute for Aging Research (HSL IFAR)). Second administrative responsibilities will be supported by the rich research infrastructures of their institutions which have a long history of collaboration. Two highly-accomplished Executive Directors will lead the teams at each site; Rosa Baier MPH (Brown) and Ellen McCarthy PhD (HSL IFAR). Third, administrative functions will be organized across eight Teams (four per site) as follows: 1. Grants Administration (Brown); 2. Organization and Logistics (Brown); 3. Institutional Review Board (IRB)/Regulatory (Brown), 4. Data Sharing and Standards (Brown), 5. Investigator Navigation (HSL IFAR), 6. Communication and Knowledge Dissemination (HSL IFAR), 7. Stakeholder Engagement (HSL IFAR), and 8. Diversity and Inclusion (HSL IFAR). Finally, specialized service providers will be engaged to manage large, critical tasks that can be done more efficiently with their expertise (e.g. website creation and maintenance, single Institutional Review Board (sIRB)). Particularly innovative functions of the Core include: organizing proactive project support, coordinating the mandatory sIRB, hosting a common REDCap database, and a dedicated Team to ensure issues related to diversity and inclusion are met in all aspects of ePCT design. IMPACT: The proposed AD/ADRD Collaboratory has all the necessary ingredients for success: strong leadership, ample resources, experts leading the Working Group Cores and Teams, and a highly-impactful agenda. However, all these elements must be supported and integrated for the Collaboratory to transform the delivery, quality, and outcomes of care for PWD and their caregivers. The Administration and Management Core serves a critical role in achieving that objective.