Administrative Core

行政核心

• 批准号: 10155437
• 负责人: Thomas D Wang
• 金额: $ 27.11万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-21 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10155437
• 关键词: Accounting; Advisory Committees; Barrett Esophagus; Budgets; Clinical Research; Communication; Contracts; Esophageal Adenocarcinoma; Grant; Investigational New Drug Application; Pharmacology and Toxicology; Pilot Projects; Procedures; Protocols documentation; Research; Tissue Banks; Validation; Work; biobank; human subject; patient registry; programs; virtual

Abstract – The Admin Core will support all grant management functions and prepare regulatory submissions for the proposed clinical studies and tissue collection. The Admin Core director will work closely with the BETRNet Steering Committee on network programs and with the PIs of Cores A and B on Research Center issues. This Core will support all grant management functions of the Research Center including budgeting, sub-contracts, and financial accounting, and to communicate with the Internal and External Advisory Committees, NCI scientific staff, BETRNet Steering Committee, and BETRNet Coordinating Center. This Core will also support all regulatory submissions for clinical studies, including human subjects protocols, Investigational New Drug (IND) Applications, analytical validation, pharmacology & toxicology studies, and standard operating procedures (SOP). This Core will also facilitate participation in all network activities, including Patient Registry-Virtual Biorepository, Pilot Projects, and Cross-BETRNet projects and communications with the Coordinating Center, Steering Committee, and NCI scientific staff.

摘要 – 管理核心将支持所有拨款管理职能并准备监管提交文件 用于拟议的临床研究和组织收集。管理核心总监将与 BETRNet 网络项目指导委员会以及研究中心核心 A 和 B 的 PI 问题。该核心将支持研究中心的所有赠款管理职能，包括预算、 分包合同、财务会计，并与内部和外部咨询进行沟通 委员会、NCI 科学人员、BETRNet 指导委员会和 BETRNet 协调中心。这个核心 还将支持临床研究的所有监管提交，包括人类受试者协议， 研究性新药 (IND) 申请、分析验证、药理学和毒理学研究，以及 标准操作程序（SOP）。该核心还将促进参与所有网络活动， 包括患者登记-虚拟生物样本库、试点项目和 Cross-BETRNet 项目以及 与协调中心、指导委员会和 NCI 科学人员的沟通。