Administrative and Clinical Research Support Core

行政和临床研究支持核心的广泛目标是提供必要的 为项目和其他核心项目提供行政和临床研究支持，这些核心对本项目的成功至关重要 计划项目拨款。核心的行政部分侧重于会计、预算编制、监管 报道，最重要的是，通过提供多个沟通机会来培养团队科学 项目和核心调查员、外部合作者和外部咨询委员会成员之间的合作。堆芯 A还将促进临床试验的启动和执行，以及对教职员工和 研究人员以及护士协调员和高级实践提供者在住院和 门诊临床单元，最大限度地提高试验的安全性和完整性。为了实现我们的目标，有4个具体的 目标：目标1：科学监督的重点是促进项目中调查人员之间的沟通 和核心，为方案团队安排年度务虚会，并与外部咨询人员举行年度会议 董事会，由免疫效应器细胞疗法领域的4位知名专家和其他主要领导人组成 在外地的特别基础上。这些项目的领导人将继续寻求在和 在项目之外与具有专业知识的调查人员合作。目标2：侧重于行政和财政支助 关于与赠款有关的总体和个别项目和核心的一般会计和财政支助， 并协助完成进度报告。目标3：侧重于临床监督和服务 向监管部门提供准备临床方案和应用程序所需的支持人员 机构，临床方案的维护，IND提交和报告的监管协助，以及 管理内部和外部机构的审计，并进行试验监测。核心A还负责 制定数据管理计划、病例报告表格和患者研究治疗日历，以及 从每个临床单位收集数据，满足与我们临床部门的数据管理协议 合作伙伴，mHealth-Fairview。目标4：教职员工教育的重点是提高员工和教职员工 在快速发展的细胞、基因和免疫治疗领域的教育。这将通过以下方式实现 常设研讨会、大型巡回会议和其他临床项目会议。在这里，我们引入了外部领导者 现场举办研讨会并与高级和初级教职员工和实习生会面，通常会带来新的 合作，扩大了我们在转化医学方面的成功。目标5：招生优化和 加强主题教育是预测和提高患者收益和 支持拟议的临床试验的受试者理解。这些工具是由调查人员在 明尼苏达大学确定累积和主题理解的障碍，允许在以下情况之前进行干预 试行启动。长期目标是快速、安全地移植同种异体免疫效应细胞。 更有效地靶向和杀死肿瘤细胞、副作用更少的癌症治疗方法。

The broad objective of the Administrative and Clinical Research Support Core is to provide essential administrative and clinical research support for the Projects and other Cores fundamental to the success of this Program Project Grant. The administrative components of the Core focus on accounting, budgeting, regulatory reporting and, most importantly, fostering team science by providing multiple opportunities for communication between project and core investigators, external collaborators and the External Advisory Board members. Core A will also facilitate clinical trial activation and execution and protocol specific training for the faculty and research staff as well as nurse coordinators and advance practice providers working in the inpatient and outpatient clinical units to maximize trial safety and integrity. To accomplish our objective, there are 4 specific aims: Aim 1: Scientific Oversight is focused on facilitating communication between investigators in projects and cores, arranging annual retreats for the Program’s team and annual meetings with an External Advisory Board, composed of 4 renowned experts in the field of immune effector cellular therapy, and other key leaders in the field on an ad hoc basis. The Programs’ leaders will continually seek areas of collaboration within and outside the Program with investigators with expertise. Aim 2: Administrative and Financial Support is focused on general accounting and fiscal support associated with the grant overall and individual projects and cores, and assistance in the completion of progress reports. Aim 3: Clinical Oversight and Services is focused on providing the support staff necessary for the preparation of clinical protocols and applications to regulatory bodies, maintenance of clinical protocols, regulatory assistance for IND submissions and reporting, and management of audits by internal and external agencies, and trial monitoring. Core A is also be responsible for development of data management plans, case report forms and patient study treatment calendars, as well as the collection of data from each of the clinical units, meeting the data management agreements with our clinical partner, MHealth-Fairview. Aim 4: Faculty and Staff Education is focused on enhancing staff and faculty education in the rapidly evolving field of cell, gene and immunotherapy. This will be accomplished through standing seminars and grand rounds and other clinical program meetings. Here, we bring in outside leaders in the field to present seminars and meet with senior and junior faculty and trainees, often leading to new collaborations, magnifying our successes in translational medicine. Aim 5: Enrollment Optimization and Enhanced Subject Education is novel unique approach for predicting and enhancing patient accrual and subject understanding in support of the proposed clinical trials. These tools developed by investigators at the University of Minnesota identify barriers to accrual and subject understanding, permitting interventions prior to trial initiation. The long-term objective is the rapid and safe translation of allogeneic immune effector cell therapies in the treatment of cancer that more effectively target and kill tumor cells with fewer adverse effects.