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Technical Information Research Resources for Cancer Preventive Agent Development

Technical Information Research Resources for Cancer Preventive Agent Development
癌症预防剂开发的技术信息研究资源
批准号：
8147322
负责人：
CAROLINE C SIGMAN
金额：
$235.38万
依托单位：
CCS ASSOCIATES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
项目状态：
已结题
起止时间：
2004-09-30 至 2011-09-29
来源：
https://reporter.nih.gov/project-details/8147322
关键词：
AddressAdverse eventAgreementAreaChemopreventive AgentClinical ProtocolsClinical ResearchComputer Systems DevelopmentDataData FilesDevelopmentDivision of Cancer PreventionDocumentationDrug ApprovalElectronicsFosteringGoalsGovernmentInformaticsInvestigational New Drug ApplicationLawsMaintenanceMalignant NeoplasmsManagement Information SystemsPaperPharmacologic SubstancePoliciesPreparationPreventiveProceduresProcessQuality ControlRecordsRegulationReportingResearchSafetyScientistSerious Adverse EventSupport ContractsUpdateWorkdesigninstrumentmeetingspre-clinicalprograms

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中文摘要
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英文摘要
The purpose of this support contract is to provide assistance to the Division of Cancer Prevention, NCI in regulatory correspondence and data file management of Investigational New Drug Applications to the FDA. The scope of work includes primarily the preparation of regulatory submissions, regulatory IND correspondence and administrative tracking, and safety activities related to adverse event reporting. Additional activities involve maintenance of collaborative research agreement records, coordination and documentation of regulatory meetings, document management, review of current regulatory guidance documents, and quality control SOPs.
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Regulatory Support for Cancer Prevention Agent Development
  • 批准号：
    9148166
  • 项目类别：
  • 资助金额：
    $220.48万
  • 财政年份：
    2015
  • 负责人：
    CAROLINE C SIGMAN
  • 依托单位：
    CCS ASSOCIATES, INC.
TECHNICAL INFORMATION RESEARCH RESOURCES FOR CANCER PREVENTIVE AGENT DEVELOPMENT
  • 批准号：
    9148165
  • 项目类别：
  • 资助金额：
    $198.36万
  • 财政年份：
    2015
  • 负责人：
    CAROLINE C SIGMAN
  • 依托单位：
    CCS ASSOCIATES, INC.
Regulatory Support for Cancer Prevention Agent Development
  • 批准号：
    9342642
  • 项目类别：
  • 资助金额：
    $227.05万
  • 财政年份：
    2015
  • 负责人：
    CAROLINE C SIGMAN
  • 依托单位：
    CCS ASSOCIATES, INC.
Regulatory Support for Cancer Prevention Agent Development
  • 批准号：
    8930897
  • 项目类别：
  • 资助金额：
    $207.04万
  • 财政年份：
    2014
  • 负责人：
    CAROLINE C SIGMAN
  • 依托单位：
    CCS ASSOCIATES, INC.
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