Administrative Core

行政核心

• 批准号: 10289494
• 负责人: Karen R Rabin
• 金额: $ 18.71万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-20 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10289494
• 关键词: Acute Lymphocytic Leukemia; Acute leukemia; Adolescent; Biological; Biology; Biometry; Budgets; Cancer Center; Child; Childhood Leukemia; Communication; Communities; Consent Forms; Data; Development; Documentation; Employment; Enrollment; Ensure; Etiology; Evaluation; Expenditure; Feedback; Funding; Hepatotoxicity; Human Resources; Institutional Review Boards; Job Description; Latino; Leadership; Logistics; Malignant Childhood Neoplasm; Methotrexate; Occupational activity of managing finances; Online Systems; Outcome; Patient advocacy; Patients; Pilot Projects; Procedures; Productivity; Protocols documentation; Questionnaires; Reporting; Research; Research Personnel; Research Training; Site; Southwestern United States; Specialized Program of Research Excellence; Specimen; Supportive care; Training; Update; Work; advocacy organizations; bilingualism; cooking; data management; data quality; ethnic disparity; genomic epidemiology; high standard; improved outcome; innovation; meetings; neurotoxicity; programs; symposium; synergism; virtual

Project Summary – Administrative Core (Core A) The proposed research program will investigate outcome disparities in Latino children and adolescents with acute lymphoblastic leukemia (ALL). The Program is built on a multi-institutional consortium, the Reducing Ethnic Disparities in Acute Leukemia (REDIAL) Consortium, comprising 6 pediatric cancer centers in the southwestern United States, with large proportions of Latino children and adolescents with acute lymphoblastic leukemia (ALL). Core A, the Administrative Core, will oversee and coordinate all entities of the Program Project to ensure maximal synergy of the Cores, Projects, and the Developmental Research Program (DRP). This Program includes: Core B, the Biospecimen Processing and Storage Core; Core C, the Biostatistics and Data Management Core; Project 1, investigating etiology and impact of ethnic disparities in therapy-associated hepatotoxicity; Project 2, investigating ethnic disparities in methotrexate neurotoxicity; and a DRP, to support the development of innovative pilot projects. By facilitating employment, training, regulatory compliance, internal and external communication, and financial management of the Program Project, Core A will maximize the productivity and efficiency of all participating Projects and Cores. Under the leadership of Co-Directors Drs. Karen Rabin and Philip Lupo, Core A will be responsible for overseeing the conduct of the research at the various sites, including the regulatory, financial, and human resources aspects. Core A will also ensure regular internal communication among investigators and sites and organize external communication with leaders in the field, the scientific community, and patient advocacy organizations. Core A will (1) oversee all human resource management responsibilities, including creation of job descriptions and the hire, evaluation, and replacement of personnel locally and at the Consortium sites; (2) provide regulatory management and governance to the Program Project, including tracking regulatory submissions/approvals and assisting with necessary training of research staff; (3) control expenditures and maintain budget information for all Projects, Cores, and Consortium sites; and (4) facilitate internal and external communication among all participating Project Leaders, Core Directors, and sites through regular meetings to ensure adequate enrollment rates, identify and solve logistical issues, and present updates on the progress of the research. An Internal Advisory Board (IAB) and External Advisory Board (EAB) will be established, both of which will include leaders in the fields of pediatric leukemia biology, genomics, epidemiology, supportive care, and patient advocacy, including two leaders of funded Specialized Programs of Research Excellence (SPOREs). There will be twice yearly meetings of the IAB and an annual virtual meeting of the EAB, during which the Project Leaders and Core Directors will present results for feedback and evaluation. In summary, the Administrative Core will ensure that all aspects of the proposed research program are conducted in accord with the highest standards of organization, documentation, communication, and fiduciary responsibility.

项目摘要--行政核心(核心A) 拟议的研究计划将调查拉丁裔儿童和青少年的结局差异 急性淋巴细胞白血病(ALL)。该计划建立在一个多机构联盟的基础上，即减少种族 由西南部6个儿科癌症中心组成的急性白血病(REDIAL)联盟的差异 在美国，有很大比例的拉丁裔儿童和青少年患有急性淋巴细胞白血病(ALL)。 核心A，即行政核心，将监督和协调计划项目的所有实体，以确保最大限度地 核心、项目和发展研究计划(DRP)的协同作用。该计划包括：CORE B，生物样品处理和储存核心；C核心，生物统计和数据管理核心；项目 1，调查治疗相关肝毒性的病因和种族差异的影响；项目2， 调查甲氨蝶呤神经毒性的种族差异；以及DRP，支持 创新试点。通过促进内部和外部的就业、培训和监管合规 计划项目的沟通和财务管理，核心A将最大限度地提高生产力和 所有参与项目和核心的效率。在联合董事凯伦·拉宾博士和 A核心的菲利普·卢波将负责监督各个地点的研究工作，包括 监管、财务和人力资源方面。核心A还将确保定期的内部沟通 在调查人员和现场之间，并组织与该领域领导人的外部交流，科学 社区和患者权益倡导组织。核心A将(1)监督所有人力资源管理 职责，包括创建工作说明以及雇用、评估和替换人员 在当地和联合体现场；(2)为计划提供监管管理和治理 项目，包括跟踪监管提交/批准和协助进行必要的研究培训 工作人员；(3)控制支出并维护所有项目、核心和联合体场地的预算信息； 以及(4)促进所有参与项目负责人、核心总监、 通过定期会议确保适当的入学率，确定和解决后勤问题，以及 介绍研究进展的最新情况。内部咨询委员会(IAB)和外部咨询委员会 (EAB)将成立，这两个组织都将包括儿童白血病生物学、基因组学、 流行病学、支持性护理和患者倡导，包括资助的专门项目的两名负责人 研究卓越(孢子)。IAB每年将举行两次会议和一次年度虚拟会议 在此期间，项目负责人和核心主管将提交结果以供反馈和评估。 总而言之，行政核心将确保实施拟议研究方案的所有方面 符合组织、文件、沟通和受托责任的最高标准。