Pharmaceutical Research Center Shared Resource

项目总结/摘要 药物研究中心（PRC）在威斯康星州大学卫生系统（UW）内运营 健康），并负责向研究提供安全和符合伦理的研究药物 受试者参加了我们医院和诊所内的所有临床药物试验，包括The University of 威斯康星州Carbone癌症中心（UWCCC）。PRC的使命是确保药物研究 方案通过已建立的药物使用系统并根据所有联邦， 管理临床研究的州、机构和申办者法规。中国服务提升监管严谨性 和受试者安全，同时促进我们的学术医学中心内的临床药物研究的进行。 对于每项临床药物试验，PRC确定研究药物的处理、分发、制备和销毁 程序;制定方案特定工作流程;创建健康研究药物专论 护理提供者;教育医疗保健人员关于协议程序;创建医嘱集; 管理药物库存和问责制;准备药物和/或监测药物准备;监测药物 失效日期和复检日期;提供质量保证稽查;并审查所有方案修订案。在 此外，PRC还提供专门针对UWCCC调查人员独特需求的服务。为 例如，PRC管理涉及基因治疗和危险肿瘤药物的试验;提供准确的 对研究者和护理提供者的药物相互作用询问做出回应;并验证授权处方者 符合NCI的要求。在当前CCSG供资周期内，PRC已启用 UWCCC研究人员实施了170项同行评审的临床药物试验，并提供了研究药物 每年平均监督200项针对癌症的临床试验。PRC致力于完善、增强和/或 扩大我们的服务，以满足UWCCC研究人员和我们的研究课题不断变化的需求， 同时在快速变化的医疗保健和监管环境中运营。我们的具体目标是：1） 提供详细的方案审查和每个UWCCC方案的可行性评估; 2）确保所有UWCCC 研究方案符合药物临床试验质量管理规范（GCP）标准; 3）提供必要的服务， 促进临床癌症研究; 4）促进UW Health卫星内的临床药物研究 在我们的集水区扩展临床癌症研究的药房。CCSG的基础资金 允许PRC领导人担任UWCCC科学领导团队的成员，以确保PRC 定位，以满足UWCCC调查人员不断变化的需求，从而提高我们的能力， 成员招募患者参加研究者发起的临床研究，最终将改善 我们的病人和社会。

PROJECT SUMMARY/ABSTRACT The Pharmaceutical Research Center (PRC) operates within the University of Wisconsin Health System (UW Health) and is responsible for the safe and ethical provision of investigational study medications to research subjects enrolled in all clinical drug trials within our hospitals and clinics, including those of The University of Wisconsin Carbone Cancer Center (UWCCC). The mission of the PRC is to ensure that drug research protocols proceed optimally through established medication use systems and in accordance with all federal, state, institutional, and sponsor regulations governing clinical research. PRC services enhance regulatory rigor and subject safety while facilitating the conduct of clinical drug research within our academic medical center. For each clinical drug trial, PRC establishes study drug handling, distribution, preparation, and destruction procedures; develops a protocol specific workflow; creates an investigational drug monograph(s) for health care providers; educates health care staff regarding protocol procedures; creates the physician orders set; manages drug inventory and accountability; prepares drugs and/or monitors drug preparation; monitors drug expiration and retest dates; provides quality assurance audits; and reviews all protocol amendments. In addition, PRC provides services that are specifically tailored to the unique needs of UWCCC investigators. For example, PRC manages trials involving gene therapy and hazardous oncology drugs; provides accurate response to drug interaction inquiries from investigators and care providers; and verifies authorized prescriber status in accordance with NCI requirements. During the current CCSG funding cycle, PRC has enabled UWCCC investigators to implement 170 peer-reviewed clinical drug trials and has provided study drug oversight for an average of 200 cancer focused clinical trials each year. PRC strives to refine, enhance and/or expand our services to meet the evolving needs of the UWCCC research faculty and our research subjects, while operating in rapidly changing healthcare and regulatory environments. Our specific aims are to: 1) provide detailed protocol review and feasibility assessment of each UWCCC protocol; 2) ensure all UWCCC study protocols comply with Good Clinical Practice (GCP) standards; 3) provide services essential to the advancement of clinical cancer research; and 4) facilitate clinical drug research within UW Health satellite pharmacies that extend clinical cancer research across our catchment area. Base funding from the CCSG allows PRC leaders to serve as members of the UWCCC scientific leadership team to ensure PRC is well positioned to meet the evolving needs of UWCCC investigators and thereby enhance the ability of our members to enroll patients onto investigator initiated clinical studies that ultimately will improve outcomes for our patients and society.