CLINICAL RESEARCH OFFICE

临床研究办公室（CRO）为在悉尼坎摩尔综合癌症中心（SKCCC）进行肿瘤研究的教职员工提供众多服务。CRO在SKCCC的研究基础设施中发挥着关键的领导作用，CRO主任负责监督和整合几个临床研究核心之间的活动。七个特定疾病研究项目的项目经理和SAC实验室经理对研究项目主任和CRO经理都有双重报告关系。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特定疾病计划的灵活性。集中和集成的CRO电子资源包括(1)临床研究管理系统（CRMS）实时跟踪所有肿瘤研究，(2)方案库包含所有有效的方案、同意书、订单集和相关文件，(3)药学研究订单跟踪/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，会议每周pre-PRMS-CRC（方案前审查和监测系统）和CRC（方案审查和监测系统）会议的结果，(5)一个标准操作程序网站，用于存放推荐的临床研究方法和程序，(6)一个监管文件仓库，提供对包括临床研究者简历和实验室证书在内的通用监管文件的集中访问，(7) SKCCC临床试验外部网站，方便社会对基于网络的临床试验进行搜索。CRO提供的教育包括为所有参与肿瘤临床试验的新研究人员提供的入门研究课程，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，并为所有研究者发起的试验提供内部监管监督和指导。质量保证服务是投诉办的重要组成部分，通过审计和监测以及制定标准操作程序。CRO作为约翰霍普金斯大学机构审查委员会、外部审计人员和监管机构的联络人。2010年有499项正在进行的研究，其中治疗性临床试验319项（干预性临床试验354项）。2010年应计项目总计6386项；包括5036项非干预研究和1350项干预试验。Lay：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，包括正规的教育计划、监管专业知识、审计和数据库，如协议库；用于跟踪登记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之间的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.