Administrative Core

行政核心

• 批准号: 10488238
• 负责人: David M. Ashley
• 金额: $ 12.35万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-13 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10488238
• 关键词: Accounting; Address; Adult Glioblastoma; Bioinformatics; Biological; Biological Markers; Budgets; Clinical Trials; Collaborations; Communication; Conflict (Psychology); Data; Data Provenance; Deoxyguanosine; Drug Targeting; Ensure; Evaluation; Expenditure; Fostering; Funding; Future; Glioblastoma; Goals; Guidelines; Infrastructure; Institution; Manuscripts; Mediating; Monitor; Occupational activity of managing finances; Office of Administrative Management; Patients; Pilot Projects; Policies; Preparation; Process; Productivity; Program Evaluation; Publications; Regulation; Reporting; Research; Research Personnel; Research Subjects; Resource Sharing; Resources; Schedule; Science; Site; Specimen; Structure; Telomerase; Therapeutic; Time; United States National Institutes of Health; Universities; Visit; biobank; conflict resolution; data integrity; data management; early phase clinical trial; immunogenic; innovation; meetings; novel; novel strategies; operation; patient population; preclinical development; professor; quality assurance; telomere

PROJECT SUMMARY – Administrative Core This Duke/UT Southwestern Glioblastoma Therapeutics Network (GTN) team will complete pre-clinical development of a novel treatment for patients with glioblastoma (GBM) and investigate the biologic activity of this agent in an early-phase clinical trial. In support of this goal, this Administrative Core is responsible for overseeing, integrating, coordinating, and supporting Projects 1 and 2 and the shared Biomarker, Bioinformatics and Biorepository Core. The Administrative Core will oversee the organizational infrastructure, integration of all components, and carry out day-to-day administrative activities; serve as the liaison with all internal and external constituencies; provide support for preparation of reports, manuscripts, and regulatory documents; and foster team science by facilitating collaboration and smooth communication through regular meetings, seminars, and other interactions. It will also provide fiscal management to ensure timely financial accounting and reporting according to university and NIH policies; provide regulatory support to ensure compliance with institutional, state, and federal research guidelines; oversee data operations to ensure use of best practices for data provenance and integrity (e.g., monitoring standards such as SOPs, GCP); provide scientific management by monitoring research progress/productivity and enable effective use of shared resource cores relative to scientific milestones and budget milestones; conduct ongoing rigorous Program evaluations, with guidance and direction provided by a Steering Committee and an Internal Advisory Board; resolve conflict; and delineate specific publication and data distribution policies. Critically, this Core will also oversee interactions with other funded GTN U19 sites, communication with Network Coordination Center, and the use of yearly trans-U19 Pilot Project Funds. This Core is structured to reduce administrative burden, allowing investigators to focus on developing a novel approach for treating adult GBM using an innovative telomerase-mediated telomere-targeting drug, 6-thio-2′- deoxyguanosine (6-thio-dG), through high-quality, rigorous, and efficient research.

项目摘要 - 行政核心 这支公爵/UT西南胶质母细胞瘤治疗学网络（GTN）团队将完成临床前 开发针对胶质母细胞瘤（GBM）患者的新型治疗方法，并研究 该代理在早期临床试验中。为了支持这个目标，该行政核心负责 监督，集成，协调和支持项目1和2和共享的生物标志物，生物信息学 和生物座核。行政核心将监督组织基础架构 组件，并进行日常行政活动；充当所有内部和外部的联络 选区；为准备报告，手稿和监管文件提供支持；和福斯特 团队科学通过常规会议，半人选和平稳沟通来促进合作和平稳的沟通 其他互动。它还将提供财政管理，以确保及时的财务会计和报告 根据大学和NIH政策；提供监管支持，以确保遵守机构，国家， 和联邦研究指南；监督数据操作以确保最佳实践用于数据propeance 和完整性（例如，监视标准，例如SOP，GCP）；通过监视提供科学管理 研究进度/生产力，并有效利用相对于科学里程碑的共享资源核心 和预算里程碑；进行持续严格的计划评估，并提供指导和指导 指导委员会和内部顾问委员会；解决冲突；并描述特定的出版物和 数据分配策略。至关重要的是，该核心也将与其他资助的GTN U19站点进行海外互动， 与网络协调中心的沟通，以及使用年度Trans-U19试点项目基金的使用。这 核心的结构是减少行政燃烧，使调查人员能够专注于开发小说 使用创新的端粒介导的端粒药物治疗成人GBM的方法，6-THIO-2'-- 通过高质量，严格且有效的研究，脱氧鸟苷（6- thio-dg）。