CORE--PROTOCOL SPECIFIC RESEARCH

核心——协议特定研究

基本信息

  • 批准号:
    7142544
  • 负责人:
  • 金额:
    $ 20.79万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2005
  • 资助国家:
    美国
  • 起止时间:
    2005-09-10 至 2010-06-30
  • 项目状态:
    已结题

项目摘要

The Protocol Management Facility participates at all levels in the activation and conduct of cancer treatment and prevention trials, including scientific and technical review, compliance with regulatory guidelines, patient registration and treatment, data management, reporting to outside sponsors, preparation of pharmacokinetic and genomic samples, and ongoing communication with principal investigators and statisticians. 147 investigators have utilized this facility during the last grant period, including 79 with peer-reviewed funding, together representing 11 Programs that span all three Divisions. With institutional support, major initiatives were undertaken in six key areas during the current grant cycle: 1) Data and Safety Monitoring: Implementation of our NCI-approved institutional master Data and Safety Monitoring Plan. A Phase l-ll Protocol Monitoring Committee was established for oversight of investigator-initiated studies not requiring a full DSMB. 2) Scientific Review: Research Review Committee chair transitioned from the Facility Director (M. Bookman) to an independent investigator (G. Hudes). Scientific Review Coordinator role established to facilitate overall review process. 3) Quality Assurance: Improved source documentation for eligibility criteria and 100% internal auditing of protocol eligibility. 4) Regulatory Support: Staff resources expanded to manage increased study volume, amendments, safety reports, adverse event reports, HIPAA documentation, sponsor communications, certifications, NCI-CTSU reporting, and global revisions to informed consent documents. 5) Informatics: Remote on-demand printing of customized patient registration packets. Generation of all protocol chemotherapy orders, including nursing documentation of drug delivery. Revision of automated reports for continuing review. Database tools for management of safety reports. 6) Centralized Research Operations: Expanded phase I program, including the protocol support laboratory. Construction of a new 17,000 square foot ambulatory care clinical research pavilion. Future initiatives include additional expansion to support the phase I program, integration of chemotherapy orders with institutional information systems, and coordination with NCI caBIG project.
议定书管理基金在所有各级参与启动和开展

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Robert C Young其他文献

Anticholinergic effects and plasma desipramine levels
抗胆碱能作用和血浆地昔帕明水平
Age and Serum Fluphenazine Concentrations
年龄与氟奋乃静血清浓度
  • DOI:
    10.1038/sj.npp.1380230
  • 发表时间:
    2003-07-25
  • 期刊:
  • 影响因子:
    7.100
  • 作者:
    James J Weisbard;Robert C Young
  • 通讯作者:
    Robert C Young

Robert C Young的其他文献

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{{ truncateString('Robert C Young', 18)}}的其他基金

CORE--RESEARCH CYTOGENETICS
核心--研究细胞遗传学
  • 批准号:
    7142523
  • 财政年份:
    2005
  • 资助金额:
    $ 20.79万
  • 项目类别:
CORE--LAB ANIMAL HEALTH
核心--实验动物健康
  • 批准号:
    7141894
  • 财政年份:
    2005
  • 资助金额:
    $ 20.79万
  • 项目类别:
CORE--HISTOPATHOLOGY
核心--组织病理学
  • 批准号:
    7142512
  • 财政年份:
    2005
  • 资助金额:
    $ 20.79万
  • 项目类别:
CORE--GENETIC MONITORING
核心——基因监测
  • 批准号:
    7141890
  • 财政年份:
    2005
  • 资助金额:
    $ 20.79万
  • 项目类别:
CORE--TUMOR BANK
核心——肿瘤库
  • 批准号:
    7142525
  • 财政年份:
    2005
  • 资助金额:
    $ 20.79万
  • 项目类别:
CORE--DNA MICROARRAY FACILITY
核心——DNA微阵列设备
  • 批准号:
    7142491
  • 财政年份:
    2005
  • 资助金额:
    $ 20.79万
  • 项目类别:
CORE--MOLECULAR MODELING FACILITY
核心——分子模拟设施
  • 批准号:
    7142498
  • 财政年份:
    2005
  • 资助金额:
    $ 20.79万
  • 项目类别:
CORE--CELL SORTING
核心——细胞分选
  • 批准号:
    7142508
  • 财政年份:
    2005
  • 资助金额:
    $ 20.79万
  • 项目类别:
CORE--HYBRIDOMA
核心--杂交瘤
  • 批准号:
    7142516
  • 财政年份:
    2005
  • 资助金额:
    $ 20.79万
  • 项目类别:
CORE--CELL CULTURE
核心--细胞培养
  • 批准号:
    7142502
  • 财政年份:
    2005
  • 资助金额:
    $ 20.79万
  • 项目类别:

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  • 批准号:
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  • 财政年份:
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