Administrative Core

行政核心

基本信息

批准号：
10683984
负责人：
Karen R Rabin
金额：
$ 49.66万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
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/10683984
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 Epidemiology Etiology Evaluation Expenditure Feedback Funding Genomics Hepatotoxicity Human Resources Institution Institutional Review Boards Job Description Latino Leadership Malignant Childhood Neoplasm Methotrexate Occupational activity of managing finances Online Systems Patient advocacy Patients Pilot Projects Procedures Productivity Protocols documentation Qualifying 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 high standard improved outcome innovation meetings neurotoxicity outcome disparities programs symposium synergism virtual

项目摘要

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果差异该计划建立在多机构联盟“Reducing Ethnic”的基础上。急性白血病差异 (REDIAL) 联盟由西南部的 6 个儿科癌症中心组成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：核心。 B，生物样本处理和存储核心；C，生物统计和数据管理核心； 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，并制定 DRP，以支持开发通过促进就业、培训、监管合规、内部和外部创新试点项目。项目核心 A 的沟通和财务管理将最大限度地提高生产力和在联合主任 Karen Rabin 和博士的领导下，所有参与项目和核心的效率。核心 A 菲利普·卢波 (Philip Lupo) 将负责监督各个地点的研究进行，包括监管、财务和人力资源方面也将确保定期的内部沟通。并组织与该领域领导者、科学界人士的外部交流社区和患者倡导组织核心 A 将 (1) 监督所有人力资源管理。职责，包括创建职位描述以及人员的雇用、评估和替换 (2) 为本计划提供监管管理和治理项目，包括跟踪监管提交/批准并协助必要的研究培训 (3) 控制支出并维护所有项目、核心和联盟站点的预算信息； (4) 促进所有参与项目负责人、核心董事之间的内部和外部沟通，通过定期会议来确保足够的入学率，确定并解决后勤问题，以及内部顾问委员会 (IAB) 和外部顾问委员会介绍研究进展的最新情况。 (EAB) 将成立，其中包括儿科白血病生物学、基因组学、流行病学、支持性护理和患者倡导，包括资助的专业项目的两位领导者卓越研究 (SPORE) 将举行两次 IAB 年度会议和一次年度虚拟会议。 EAB 期间，项目负责人和核心董事将提交结果以供反馈和评估。总之，行政核心将确保拟议研究计划的各个方面都得到实施符合组织、文件、沟通和信托责任的最高标准。