CLINICAL RESEARCH OFFICE

临床研究办公室（CRO）为Sidney Kimmel综合癌症中心（SKCCC）进行肿瘤学研究的教职员工提供多种服务。CRO在SKCCC研究基础设施中发挥关键领导作用，CRO总监负责监督和整合多个临床研究核心之间的活动。七个疾病特异性研究项目的项目经理和SAC实验室经理与研究项目总监和CRO经理有双重报告关系。这允许集中的研究基础设施，但同时允许基于正在研究的疾病的疾病特异性计划的灵活性。集中和集成的CRO电子资源包括（1）临床研究管理系统（CRMS），跟踪所有肿瘤学研究的真实的时间累积，（2）包含所有有效方案、同意书、订单集和相关文件的方案库，（3）药房研究订单跟踪/批准系统（POTS），（4）方案审查和监测系统-临床研究审查委员会（PRMSCRC）电子论坛跟踪文件，科学审查意见，以及每周PRMS-CRC前会议的结果（议定书前审查和监测系统）和化学品审查委员会（方案审查和监测系统）会议，（5）标准操作程序网站，用于容纳推荐的临床研究方法和程序，（6）监管文件仓库，提供对常见监管文件的集中访问，包括临床研究者简历和实验室认证，以及（7）SKCCC外部临床试验网站，以方便社区进行基于网络的临床试验搜索。CRO提供的教育包括为所有参与肿瘤学临床试验的新研究人员提供的介绍性研究课程、CRMS培训以及为研究教职员工提供的继续研究教育。CRO提供有关FDA法规和研究性新药（IND）提交的监管专业知识，以及对所有由CRO发起的试验的内部监管监督和指导。质量保证服务是CRO的重要组成部分，通过审计和监测以及制定标准操作规程。CRO负责与约翰霍普金斯机构审查委员会、外部稽查员和监管机构进行联络。2010年，有499项正在进行的研究，包括319项治疗性（354项干预性）临床试验。2010年累计6，386例，包括5，036例非干预性研究和1，350例干预性试验。铺设：临床研究办公室（CRO）为临床试验的开展提供了一个集中的基础设施，包括正规教育计划、监管专业知识、稽查和数据库，如方案库;用于跟踪入组的临床研究管理系统（CRMS）和药房订单跟踪系统（POTS）。CRO在整合其他临床研究核心活动方面发挥着关键作用。SKCCC管理共享资源当前资助年度报告期：2010年1月1日至2010年12月31日

The Clinical Research Office (CRO) provides numerous services to faculty and staff conducting oncology research at the Sidney Kimmel Comprehensive Cancer Center (SKCCC). The CRO has a key leadership role in the SKCCC research infrastructure, with the CRO Director overseeing and integrating activities among the several Clinical Research Cores. The Program Managers of the seven disease-specific research Programs and the SAC lab Manager have a dual-reporting relationship to both the Research Program Directors and the CRO Manager. This allows for a centralized research infrastructure yet at the same time allows disease-specific Programs flexibility based on the disease(s) being studies. Centralized and integrated CRO electronic resources include (1) a Clinical Research Management System (CRMS) tracking real time accrual to all oncology research studies, (2) a Protocol Library containing all active protocols, consents, order sets, and related documents, (3) a Pharmacy Research Orders Tracking/Approval System (POTS), (4) the Protocol Review and Monitoring System-Clinical Research Review Committee (PRMSCRC) Electronic Forum tracking documents, scientific review comments, and meeting outcomes from the weekly pre-PRMS-CRC (pre-Protocol Review and Monitoring System) and CRC (Protocol Review and Monitoring System) meetings, (5) a Standard Operating Procedures website for housing recommended clinical research methods and procedures, (6) a Regulatory Documents Warehouse to provide centralized access to common regulatory documents including clinical investigator CVs and laboratory certifications, and (7) an external SKCCC Clinical Trials website to facilitate web-based clinical trials searches by the community. Education provided by the CRO includes an introductory research course for all new research staff involved in oncology clinical trials, CRMS training, and continuing research education for research faculty and staff. The CRO provides regulatory expertise regarding FDA regulations and Investigational New Drug (IND) submissions, and internal regulatory oversight and guidance for all investigator-initiated trials. Quality assurance services are an essential component of the CRO via auditing and monitoring and developing standard operating procedures. The CRO acts as a liaison with the Johns Hopkins Institutional Review Boards, outside auditors and regulatory agencies. In 2010, there were 499 active research studies, including 319 therapeutic (354 Intervention) clinical trials. Accruals in 2010 totaled 6,386; including 5,036 to non-intervention studies and 1,350 to intervention trials. Lay: The Clinical Research Office (CRO) provides a centralized infrastructure for the conduct of clinical trials, including formal education programs, regulatory expertise, auditing, and databases such as a Protocol Library; a Clinical Research Management System (CRMS) for tracking enrollment, and a Pharmacy Orders Tracking System (POTS). The CRO plays a key role in integrating activities among the other clinical research cores. SKCCC Managed Shared Resource Current Grant Year Reporting Period: January 1, 2010 to December 31, 2010