Investigational Drug

由药学博士Barbara Todaro领导的毒品调查服务局(IDS)在 RPCI研究。IDS工作人员负责研究药物管理的方方面面， 包括问责、订购、接收、销毁、退货、妥善储存和分发。ID 药剂师为登记参加临床研究的患者提供药物咨询。他们也 在研究研究的筛查中为患者提供药物调节，这一点已在 电子病历(EMR)。研究研究的数量和复杂性，特别是第一阶段 研究是药剂部和临床部创建入侵检测系统的驱动力 协议和数据管理(CPDM)办公室。 需要八(8)个FTE来支持所有RPCI临床研究。入侵检测系统工作人员的职责 包括对SRC和IRB提交研究审查、修订审查、修订调查员审查 宣传册、研究实施、配药和无菌产品准备，以及临床服务，如 用药审查和病人咨询。一名入侵检测系统工作人员还参与实施 RPCI临床研究网络中由研究人员发起的研究。入侵检测系统工作人员提供专家 为每一项利用医药产品的临床研究提供咨询。 Todaro博士是第一阶段委员会的联合主席，并为35个第一阶段提供咨询 在之前的获奖期内由研究人员发起的研究。在托达罗博士的指导下，报道 不良事件、剂量限制毒性和第一阶段患者监测的流程已更新为 及时向机构审查委员会(IRB)提供必要的关键信息。 在提交本报告时，内务部负责了300多项调查项目，其中150项 用于80项临床研究的研究性药物或项目。一名入侵检测系统成员参加所有学习启动 开会。2012年共召开了53次临床研究实施会议。 利用入侵检测系统资源的优先顺序如下：优先使用由同行审查资助的资源 RPCICCSG成员；非同行审查资助的CCSG成员第二优先；非成员第三优先 和学术合作者；最后优先考虑外部用户。在本报告所述期间，入侵检测系统 为来自6个研究项目的28名成员提供服务，CCSG成员在同行评审的情况下利用率为63% 资金问题。CCSG占整个拟议预算的3%。此应用程序寻求0.14 FTE支持 主任，由机构来源和研究赞助者提供工作人员支助 (NIH/CTEP，工业，基金会)。

The Investigational Drug Service (IDS), directed by Barbara Todaro, PharmD, plays a critical role in RPCI research. IDS staff members are responsible for all aspects of investigational drug management, including accountability, ordering, receiving, destruction, returns, proper storage and dispensing. IDS pharmacists provide medication counseling for patients enrolled in clinical research studies. They also provide medication reconciliation for patients in screening for a research study, and this is documented, in the electronic medical record (EMR). The number and complexity of research studies, especially Phase 1 studies, were the driving forces behind the creation of IDS by the Department of Pharmacy and the Clinical Protocol and Data Management (CPDM) office. Eight (8) FTEs are required to support all RPCI clinical research studies. Responsibilities of IDS staff include study review for SRC and IRB submission, amendment review, review of amended investigator brochures, study implementation, dispensing and sterile products preparation, and clinical services such as medication review and patient counseling. An IDS staff member is also involved with implementation of Investigator-Initiated studies in the RPCI Clinical Research Network. IDS staff members provide expert consultation for each clinical research study utilizing pharmaceutical products. Dr. Todaro is the Co-Chair of the Phase 1 Committee and has provided consultation for thirty-five Phase I Investigator-Initiated studies during the previous award period. Under Dr. Todaro's direction, the reporting processes for adverse events, dose limiting toxicities and phase 1 patient monitoring have been updated to provide the Institutional Review Board (IRB) with necessary critical information in a timely manner. At the time of this submission, IDS was responsible for more than 300 investigational items, with 150 investigational drugs or items for 80 clinical research studies. A member of IDS attends all study initiation meetings. There were 53 implementation meetings for clinical research studies in 2012. Utilization of IDS resources is prioritized as follows: First priority for use is given to peer-review-funded RPCI CCSG members; second priority to non-peer-review-funded CCSG members; third priority to nonmembers and academic collaborators; and last priority to external users. During the reporting period, IDS served 28 members from 6 research programs, with 63% utilization by CCSG members with peer reviewed funding. The CCSG makes up 3% of the overall proposed budget. This application seeks 0.14 FTE support for the Director, with staffing support to be provided by institutional sources as well as study sponsors (NIH/CTEP, industry, foundations).