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

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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