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）为癌症中心研究人员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文件、在确认患者资格后将患者注册到已批准的临床试验中，以及协助进行数据分析。此外，CTO还充当机构审查委员会（IRB）的接口，以方便准备所需的同意和HIPAA表格，以及其他必要的监管文件

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.