Core--Clinical Trials Office

核心--临床试验办公室

• 批准号: 7038855
• 负责人: JOHN C RUCKDESCHEL
• 金额: $ 20.77万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7038855
• 关键词: biomedical facility; clinical trials; data management; health science research analysis /evaluation; neoplasm /cancer

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.

临床试验核心是综合癌症中心不可或缺的一部分。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：制定方案、通过Karmanos网站收集和传播带有支持文件的方案信息、在确认患者资格后将患者登记到已批准的临床试验中，以及协助数据分析。此外，CTO作为与机构审查委员会(IRB)的接口，以促进准备所需的同意书和HIPAA表格，以及其他必要的监管文件 加快癌症中心方案的有效审查和开放。CTO临床试验的范围包括国家合作小组、工业、NCI赞助、机构和研究人员发起的工业赞助研究。首席技术官为临床试验议定书审查和监测进程的所有努力提供支持。CTO向协议审查和监督委员会、数据和安全监测委员会以及质量保证委员会提供行政支持。该中心为研究人员提供关于方案指南的咨询功能；所有临床试验的中央储存库；并保证研究人员遵守良好的临床实践指南。CTO与生物统计核心进行交互，并定期与提供统计数据的共享资源一起工作 审查并协助CTO设计和实施研究特定的数据库屏幕，以及机构临床试验的病例报告表格。总体而言，39.95人作为CTO成员提供数据管理服务，支持300多项积极研究。这些活动的结果是，在这一赠款期间，临床试验的应计收益水平保持不变，少数族裔和妇女的代表性更好，反映了癌症中心所服务的社区。