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中文摘要
翻译
药物研究中心(PRC)(以前称为研究药物服务/IDS)确保 向入组临床药物研究受试者安全和合乎伦理地提供研究药物 UWCCC内部的试验。它确保药物研究方案通过大学以最佳方式进行。 威斯康星州医院和诊所(UWHC)的药物使用系统并符合所有联邦、州、 机构和赞助商法规:服务不断完善和扩展,以满足 UWCCC临床研究不断发展的需求。虽然UW/UWHC的PRC计划支持所有 研究人员进行临床药物研究,它与UWCCC的关系是独一无二的, 承诺,提供的服务的广度和深度,以及处理生物危害和基因的专业知识 治疗产品。PRC提供详细的方案审查和可行性评估, 一个学术医疗中心的。它确保完全符合联邦、州、申办者和机构 通过以下活动满足需求:建立药物处理/分销/制备/销毁机制 程序;为医疗保健提供者编写研究药物专论;医疗保健教育 关于方案程序的工作人员;创建预先打印的医嘱和处方;药物库存 管理和问责;药物制备和/或监督;质量保证稽查;以及方案 修订管理。它运营卫星药房位置,优化扩展临床 研究社区。
英文摘要
The Pharmaceutical Research Center (PRC) (previously named Investigational Drug Services/IDS) ensures the safe and ethical provision of investigational/study drugs to research subjects enrolled in clinical drug trials within the UWCCC. It ensures that drug research protocols proceed optimally through the University of Wisconsin Hospital and Clinics' (UWHC) medication use system and in accordance with all federal, state, institutional and sponsor regulations: The services are continually refined and expanded to meet the evolving needs of the UWCCC clinical research. While the PRC program at UW/UWHC supports all investigators conducting clinical drug research, its relationship with the UWCCC is unique in its level of commitment, the breadth and depth of services provided, and expertise in handling biohazardous and gene therapy products. The PRC provides detailed protocol review and feasibility assessment within the confines of an academic medical center. It ensures full compliance with federal, state, sponsor and institutional requirements through activities such as: establishment of drug handlihg/distribution/preparation/destruction procedures; creation of investigational drug monographs for health care providers; education of health care staff regarding protocol procedures; creation of preprinted physician orders and prescriptions; drug inventory management and accountability; drug preparation and/or oversight; quality assurance audits; and protocol amendment management. It operates satellite pharmacy locations, optimizing ability to extend clinical research into the community.
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Pharmaceutical Research Center
  • 批准号:
    8250412
  • 项目类别:
  • 资助金额:
    $8.56万
  • 财政年份:
    2011
  • 负责人:
    Rebecca Marnocha
  • 依托单位:
Pharmaceutical Research Center
  • 批准号:
    7491887
  • 项目类别:
  • 资助金额:
    $10.28万
  • 财政年份:
    2007
  • 负责人:
    Rebecca Marnocha
  • 依托单位:
Pharmaceutical Research Center Shared Resource
  • 批准号:
    9923027
  • 项目类别:
  • 资助金额:
    $9.07万
  • 财政年份:
    --
  • 负责人:
    Rebecca Marnocha
  • 依托单位:
Pharmaceutical Research Center
  • 批准号:
    7726687
  • 项目类别:
  • 资助金额:
    $9.68万
  • 财政年份:
    --
  • 负责人:
    Rebecca Marnocha
  • 依托单位:
海外基金