Core--Clinical Trials Office

临床试验中心是综合癌症中心的一个组成部分。临床试验办公室（CTO）为癌症中心研究者进行的临床研究提供集中的数据管理支持。这种支持包括但不限于方案制定、集中数据收集和通过Karmanos网站传播方案信息及支持性文件、在确认患者资格后将患者登记到批准的临床试验中以及协助数据分析。此外，CTO还充当机构审查委员会（IRB）的接口，以便于准备所需的知情同意书和HIPAA表格以及其他必要的监管文件， 加快有效审查和开放癌症中心协议。CTO临床试验的范围包括国家合作组、行业、NCI申办的、机构和研究者发起的、行业申办的研究。CTO为临床试验方案审查和监测过程的所有工作提供支持。CTO向方案审查和监测委员会、数据和安全性监测委员会以及质量保证委员会提供行政支持。核心为研究者提供有关方案指南的咨询功能;所有临床试验的集中存储库;以及保证研究者遵守药物临床试验质量管理规范指南。CTO与生物统计核心交互，并定期与提供统计数据的共享资源合作。 审查并协助CTO设计和实施研究特定数据库筛选以及机构临床试验的病例报告表。总的来说，39.95人作为CTO成员提供数据管理服务，支持300多项正在进行的研究。这些活动导致在此赠款期间临床试验的累积水平恒定，少数民族和妇女的代表性更好，反映了癌症中心所服务的社区。

The Clinical Trials Core is an integral part of the Comprehensive Cancer Center. The Clinical Trials Office (CTO) provides centralized data management support for clinical research conducted by the Cancer Center investigators. This support includes, but is not limited to, protocol development, centralized data collection and dissemination of protocol information with supporting documents via the Karmanos website, registration of patients onto approved clinical trials following confirmation of patient eligibility, and assistance in data analysis. Additionally the CTO serves as an interface with the Institutional Review Board (IRB) to facilitate preparation of the required consent and HIPAA forms, and other regulatory documents necessary to expediate effective review and opening of cancer center protocols. The scope of the CTO clinical trials includes national cooperative groups, industrial, NCI sponsored, institutional, and investigator initiated, industrial sponsored studies. The CTO provides support to all of the efforts of the Protocol Review and Monitoring Process for clinical trials. CTO administrative support is provided to the Protocol Review and Montioring Committee, Data & Safety Monitoring Committee, and Quality Assurance Committee. The Core provides an advisory function for investigators regarding protocol guidelines; centralized repository of all clinical trials; and assurance of Investigator Compliance with Good Clinical Practice Guidelines. The CTO interacts with the Biostatistical Core, and routinely works with the shared resource who provides statistical review and assists the CTO in the design and implementation of study specific database screens, and case report forms for instituional clinical trials. Overall, 39.95 individuals provide data management services as members of the CTO supporting more than 300 active studies. These activities have resulted in a constant level in accrual to clinical trials during this grant period with more then excellent representation of minorities, and women that reflect the community that the Cancer Center serves.