Administrative Core

行政核心

基本信息

批准号：
8244094
负责人：
Thomas D Wang
金额：
$ 19.02万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-21 至 2016-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8244094
关键词：
Accounting Adenocarcinoma Administrator Algorithms Barrett Esophagus Binding Biopsy Budgets Case Report Form Clinical Clinical Research Collection Color Consent Forms Contracts Coumarins Custom Detection Development Dysplasia Early Diagnosis Endoscopes Esophagus Fiber Fluorescein Fluorescein-5-isothiocyanate Fluorescence Future Grant Human Resources Image Institution Institutional Review Boards Investigation Label Light Maps Measures Michigan Neoplasms Pathology Patient Recruitments Patients Peptides Performance Pharmaceutical Preparations Pharmacology and Toxicology Phase Pilot Projects Progress Reports Protocols documentation Research Research Project Grants Research Support Resolution Resources Scanning Schedule Screening for cancer Screening procedure Signal Transduction Site System Teleconferences Testing Time Tissue Procurements Training United States Food and Drug Administration Universities Validation Variant Washington Work alpha benzopyrone base cost design fluorescence imaging human subject improved in vitro testing in vivo instrument phase 1 study programs prototype surveillance strategy validation studies working group

项目摘要

Core Summary: The Administration Shared Research Resource (Core A) will support the grants and regulatory management needs for the three research projects, developmental (pilot) projects, cross-BETRNet projects, and other cross-BETRNet activities. Grant management responsibilities include preparing and implementing the Research Center budgets, allocating sub-contracts to participating institutions, performing financial accounting, and communicating with the NCI program managers. In addition, this Core will prepare the Research Center progress reports, set up the regularly scheduled teleconferences, and support the BETRNet working groups. Furthermore, this Core will fulfill the regulatory management responsibilities, including preparing the human subjects protocols for the clinical studies and tissue procurement protocols for the validation studies. This Core will communicate with the institutional IRB and prepare consent forms, case report forms, and patient recruitment tables for the Phase 1 studies. In addition, this Core will arrange for the pharmacology & toxicology studies on the peptides to be performed, work with MICHR to prepare the Investigation of New Drug applications to the US Food and Drug Administration (FDA). This Core is led by the Director Dr. TD Wang with support from the Research Center grants administrator Ms. Michele Bushaw Weston.

核心摘要：政府共享研究资源（核心A）将支持赠款和对三个研究项目，开发项目（试点）项目，跨跨网络项目和其他跨发网络活动的监管管理需求。赠款管理职责包括准备和实施研究中心的预算，将分包合同分配给参与机构，进行财务会计以及与NCI计划经理进行沟通。此外，该核心将准备研究中心的进度报告，设置定期安排的电视会议并支持BETRNET工作组。此外，该核心将履行监管管理职责，包括为临床研究和组织采购方案准备人类主题方案。该核心将与机构IRB进行通信，并为第1阶段研究准备同意书，案例报告表和患者招聘表。此外，该核心将安排有关要进行的肽的药理学和毒理学研究，并与MICHR合作，为美国食品药品管理局（FDA）的新药物应用进行调查。该核心由TD Wang博士主任，在研究中心授予管理员Michele Bushaw Weston女士的支持下。