Administrative Core

行政核心

• 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
• 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

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， 三个研究项目、开发（试点）项目、跨BETRNet项目和其他跨BETRNet活动的监管管理需求。补助金管理职责包括编制和实施研究中心预算，将分包合同分配给参与机构，执行财务会计，以及与NCI项目经理沟通。此外，该核心将准备研究中心的进度报告，建立定期安排的电话会议，并支持BETRNet工作组。此外，该核心将履行监管管理职责，包括为临床研究编写人类受试者方案和为确认研究编写组织采购方案。该核心将与机构IRB沟通，并为I期研究准备知情同意书、病例报告表和患者招募表。此外，该核心将安排对肽进行药理学和毒理学研究，与MICHR合作准备向美国食品药品监督管理局（FDA）提交新药申请的调查。该核心由主任王道明博士领导，并得到研究中心赠款管理员米歇尔·布斯顿韦斯顿女士的支持。