Administrative and Clinical Research Support Core

行政和临床研究支持核心

• 批准号: 10554608
• 负责人: John E. Wagner
• 金额: $ 14.91万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-15 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10554608
• 关键词: Acceleration; Accounting; Adverse effects; Agreement; Allogenic; Area; Augmented Reality; Autologous; Budgets; Calendar; Case Report Form; Cell Therapy; Cells; Cellular immunotherapy; Clinical; Clinical Data; Clinical Nursing Research; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Communication; Complex; Data Collection; Development; Devices; Education; Effectiveness; Effector Cell; Enrollment; Ensure; Evaluation; Expenditure; Faculty; Feedback; Financial Support; Fostering; Funding; Genes; Goals; Grant; Health; Hematologic Neoplasms; High-Risk Cancer; Immune; Immunotherapy; Individual; Inpatients; Intervention; Joints; Knowledge; Laboratories; Leadership; Maintenance; Management Audit; Minnesota; Monitor; Nurses; Nursing Research; Outpatients; Output; Patients; Phase; Phase II Clinical Trials; Preparation; Productivity; Program Research Project Grants; Progress Reports; Protocols documentation; Provider; Public Health Informatics; Reporting; Research; Research Assistant; Research Personnel; Research Support; Safety; Science; Services; Strategic Planning; Teacher Professional Development; Translations; United States National Institutes of Health; Universities; cancer therapy; clinical application; clinical translation; clinical trial implementation; data management; experience; first-in-human; improved; mHealth; meetings; member; multiple data sources; neoplastic cell; new technology; novel; novel strategies; patient safety; prediction algorithm; programs; protocol development; public health relevance; recruit; side effect; success; therapy development; timeline; tool; translational medicine; tumor

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.

行政和临床研究支持核心的广泛目标是提供必不可少的 对这些项目的行政和临床研究支持，以及其他核心的基础 计划项目赠款。核心的行政组成部分关注会计，预算，监管 报告，最重要的是，通过提供多种沟通机会来促进团队科学 在项目和核心调查人员之间，外部合作者和外部顾问委员会成员之间。核 A还将促进临床试验激活和执行和协议的特定培训，并 研究人员以及护士协调员和在住院和工作的前进实践提供者 门诊临床单位，以最大化试验安全性和完整性。为了实现我们的目标，有4个特定的 目的：目标1：科学监督专注于促进研究人员之间的沟通 和核心，安排该计划团队的年度务虚会，并与外部咨询 董事会，由4位在免疫效应蜂窝疗法领域的知名专家和其他主要领导者组成 在现场临时。该计划的领导人将不断寻求在内部和 在计划之外，具有专业知识的调查员。目标2：行政和财政支持集中 关于一般会计和财政支持与赠款的总体以及个人项目和核心相关的 以及完成进度报告的帮助。目标3：临床监督和服务重点 提供准备临床方案和申请进行监管所需的支持人员 机构，维护临床方案，有关IND提交和报告的监管援助以及 内部和外部机构对审计的管理以及试用监控。核心A也负责 制定数据管理计划，案例报告表和患者研究治疗日历以及 从每个临床单位收集数据，与我们的临床达成数据管理协议 MHealth-Fairview合作伙伴。 AIM 4：教职员工教育专注于增强员工和教职员工 在细胞，基因和免疫疗法的快速发展领域的教育。这将通过 站立的下水道和大回合以及其他临床计划会议。在这里，我们引进了外部领导者 该领域介绍半人，并与高级和初级教师和培训会面，通常会导致新 合作，放大了我们在翻译医学方面的成功。目标5：注册优化和 增强学科教育是预测和增强患者准确性和增强的新型独特方法 主题的理解以支持拟议的临床试验。这些工具是由调查员开发的 明尼苏达大学确定了对主体和主题理解的障碍，允许在进行干预措施 审判计划。长期目标是同种异体免疫效应细胞的快速和安全翻译 癌症治疗的疗法更有效地靶向和杀死肿瘤细胞，较少的不良反应。