Core 3: Communications, Administrations, Advocacy, and Project Management

该方案项目包括四个综合项目，以开发和维护开发和维护基础设施 在I-SPY2.2试验中实施改进，采用早期升级/降级治疗并确定 在监管证据生成框架内优化患者结局的治疗策略。主要目标是 通信、行政、宣传和项目管理(CAAP)的核心是确保计划 通过提供项目管理、领导力、 向所有项目和核心提供行政支助；以及将宣传纳入面向病人的所有方面 计划项目中的项目和核心。 也许CAAP核心最关键的作用是协调项目和核心的活动和交付成果 由研究赞助商QLHC、其临床操作团队和I-SPY2试验工作组主席组成。While计划 项目人员、核心和项目的任务是制定和完善技术和方法进步 在I-SPY2.2中采用的持续改进方法中所要求的，试验的所有操作方面是 研究赞助商的责任。由CAAP核心推动的方案项目总体绩效指标和项目绩效指标的工作 通过定义技术标准，将变更整合到与赞助商代表一起的试验操作中 赞助商临床运营团队的要求、规格和交付内容。 在其他职责中，CAAP核心确保我们的患者权益倡导者在所有项目团队中都有代表， 核心团队和项目间协作，以便他们能够带来他们独特和重要的视角来帮助满足 I-SPY2.2的以患者为中心的任务。 具体目标1：组织、整合和提供所有项目和核心的行政管理 具体目标2：提供项目管理监督，以跟踪各个项目的里程碑和时间表 核心。 具体目标3：促进协作和传播信息

The Program Project encompasses four integrated projects to develop and maintain the infrastructure for developing and implementing improvements in the I-SPY2.2 trial that employs early escalation/de-escalation of treatment and identifies treatment strategies to optimize patient outcomes within a regulatory evidence generation framework. The primary aims of the Communications, Administration, Advocacy, and Project management (CAAP) Core are to ensure program integration, collaboration, patient acceptance, and regulatory compliance by providing project management, leadership, and administrative support to all Projects and Cores; as well as the integration of advocacy in all patient-facing aspects of the Projects and Core in the Program Project. Perhaps the most critical role of the CAAP core is to coordinate the activities and deliverables of the projects and cores with the study sponsor QLHC, its clinical operations team and the I-SPY2 trial working group chairs. While program project personnel, cores and projects are tasked with developing and refining the technical and methodological advances required in the continuous improvement approach employed in I-SPY2.2, all operational aspects of the trial are the responsibility of the study sponsor. The Program Project overall PIs and project PIs, facilitated by the CAAP core, work to integrate the changes into the operations of the trial with sponsor representatives by defining the technical requirements, specifications, and deliverables for the sponsor’s clinical operations team. Among its other responsibilities, the CAAP Core ensures that our patient advocates are represented on all project teams, cores teams and inter-project collaborations, so that they can bring their unique and important perspective to help meet the patient-centric mandate of I-SPY2.2. Specific Aim 1: Organize, integrate, and provide administrative management of all Projects and Core Specific Aim 2: Provide project management oversight to track milestones and timelines of the individual Projects and Cores. Specific Aim 3: Facilitate collaborations and disseminate information