Research Pharmacy

项目摘要/摘要 建立了研究药房(研究药物服务)共享资源(SR)，以 支持Sidney Kimmel研究人员进行的住院和门诊临床研究 综合癌症中心(SKCCC)研究药房的工作人员与 SKCCC临床研究办公室、疾病小组、个人研究人员和Weinberg肿瘤学 药房临床工作人员协调和促进开发、实施和维护 临床试验方案。研究药房提供的服务包括方案咨询、临床数据 监测、调查产品管理、参与电子订单集开发过程、 监测患者研究产品的依从性，提供质量保证活动，提供药物 信息和药物相互作用审查、IRB成员资格和疾病组织的资源，以及其他 支持研究团队的服务。该SR完全集成在SKCCC肿瘤学药房中，并且是 这是SKCCC研究工作不可或缺的一部分。这种集成允许对研究提供额外的支持 通过将药房临床专家的专业知识和与肿瘤学的合作纳入参与者 药房人员和技术支持生产。 SR工作人员包括一名药剂部主任，一名运营经理，四个临床研究 药剂师、1名临床决策支持药剂师、2名执业药房技术员和1名执业药剂师 药房技术员/库存专家。研究人员和研究人员可以获得药房支持 24/7全天候患者护理服务团队。研究药房符合马里兰药房委员会的规定 条例，美国药典(USP)第797章，药物无菌复方条例， 并根据州、联邦和约翰霍普金斯医学机构审查委员会的规定进行 研究。在即将到来的药房完工时，将完全遵守USP第800章的规定 计划于2021年秋季进行翻修。当前的重点领域是改善服务和提供特殊护理 肿瘤学研究参与者包括药物安全倡议、探索新技术和创新 开展治疗学临床研究中开展临床药学服务的实践 集团(第一阶段)，支持研究扩展倡议，并促进国家 研究药物和研究的认可药房实习计划。 SKCCC托管共享资源 报告期：2020年1月1日至2020年12月31日

PROJECT SUMMARY/ABSTRACT The Research Pharmacy (Investigational Drug Service-IDS) Shared Resource (SR) was established to support inpatient and outpatient clinical research conducted by investigators at the Sidney Kimmel Comprehensive Cancer Center (SKCCC). The Research Pharmacy staff work in close collaboration with the SKCCC Clinical Research Office, disease groups, individual investigators and the Weinberg Oncology Pharmacy clinical staff to coordinate and facilitate the development, implementation and maintenance of clinical trial protocols. Services provided by the Research Pharmacy include protocol consultation, clinical data monitoring, investigational product management, participation in the electronic order set development process, monitoring patient investigational product adherence, providing quality assurance activities, providing drug information and drug-drug interaction reviews, IRB membership and resources to disease groups, and other services to support the study teams. This SR is fully integrated within the SKCCC Oncology Pharmacy and is an integral part of the SKCCC's research efforts. This integration allows for additional support to research participants by incorporating pharmacy clinical specialists' expertise and collaboration with Oncology Pharmacy staff and technology to support production. The SR staff include a Pharmacy Division Director, an Operations Manager, four Clinical Research Pharmacists, one Clinical Decision Support Pharmacist, two Certified Pharmacy Technicians and one Certified Pharmacy Technician/Inventory Specialist. Pharmacy support is available to investigators and the research teams for patient care services 24/7. The Research Pharmacy is compliant with Maryland Board of Pharmacy regulations, United States Pharmacopeia (USP) Chapter 797, pharmaceutical sterile compounding regulations, and with state, federal and Johns Hopkins Medicine Institutional Review Board regulations for the conduct of research. Compliance with USP Chapter <800> will be fully instituted at the completion of upcoming pharmacy renovations planned for fall 2021. Current areas of focus to improve services and provide exceptional care to oncology study participants include medication safety initiatives, exploring new technology and innovative practices, implementing clinical pharmacy services within the Developmental Therapeutics Clinical Research Group (Phase I), supporting research expansion initiatives, and facilitating residency training of a nationally accredited pharmacy residency program for investigational drugs and research. SKCCC Managed Shared Resource Reporting Period: January 1, 2020 to December 31, 2020