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.

项目概要-行政核心 这个杜克/UT西南胶质母细胞瘤治疗网络（GTN）团队将完成临床前 为胶质母细胞瘤（GBM）患者开发一种新的治疗方法，并研究 这种药物的早期临床试验为支持这一目标，该行政核心负责 监督、整合、协调和支持项目1和2以及共享的生物标志物、生物信息学 和生物储藏核心行政核心将监督组织基础设施，整合所有 各组成部分，并进行日常行政活动;作为联络所有内部和外部 赞助者;为编写报告、手稿和规范性文件提供支持;并促进 通过定期会议、研讨会和 其他互动。它还将提供财务管理，以确保及时进行财务会计和报告 根据大学和NIH的政策;提供监管支持，以确保遵守机构，州， 和联邦研究指南;监督数据操作，以确保使用数据出处的最佳实践 和完整性（例如，监控标准，如SOP、GCP）;通过监控提供科学管理 研究进展/生产力，并能够有效利用与科学里程碑相关的共享资源核心 和预算里程碑;进行持续的严格的计划评估，并提供指导和方向 一个指导委员会和一个内部咨询委员会;解决冲突;界定具体的出版物， 数据分发政策。至关重要的是，该核心还将监督与其他受资助的GTN U19网站的互动， 与网络协调中心的沟通，以及每年跨U19试点项目资金的使用。这 核心的结构是为了减少行政负担，使调查人员能够专注于开发一个新的 使用创新的端粒酶介导的端粒靶向药物6-硫代-2 ′- 脱氧鸟苷（6-硫代-dG），通过高质量，严格和有效的研究。