Early Phase Clinical Research Support

癌症治疗研究中心(CTRC)的临床方案和数据管理部分 包括临床试验办公室(CTO)和数据和安全监测委员会(DSMC)的活动 包括质量保证部(QAD)。首席技术官提供集中管理、研究支持 以及监督开展与癌症有关的临床试验的职能。CTO服务包括 可供所有从事临床研究的CTRC成员使用；然而，一些研究人员选择使用 他们部门内的研究人员与CTO协同工作，提供伞式监督。少校 CTRC首席技术官的职能是： 促进临床试验的及时启动和管理，包括筹备和沟通 科学、伦理、运营和后勤审查所需 ·确保研究团队接受了充分的培训，以支持每项试验 ·维护所有特定于协议的文件和同意书的基于Web的中央存储库 提供临床援助以促进临床试验的进行，包括但不限于登记 和验证患者的资格，安排适当的测试、治疗和评估 ·为临床试验提供数据管理支持 QAD与CTO分开，以最大限度地减少冲突。与DSMC合作，QAD的功能 目标是： 确保所有报告，包括严重不良事件和意外问题的报告， 根据适当的指导方针提交。 确保协议符合机构政策和协议、州和联邦法规、数据 通过监测和质量保证系统确保准确性和数据完整性 向研究人员提供关于进行临床试验的最佳实践的培训和教育 工作人员。

The Clinical Protocol and Data Management component of the Cancer Therapy & Research Center (CTRC) includes the Clinical Trials Office (CTO) and Data and Safety Monitoring Committee (DSMC) activities including the Quality Assurance Division (QAD). The CTO provides central management, research support and oversight functions for the conduct of cancer-related clinical trials at the CTRC. CTO services are available to all members of CTRC engaged in clinical research; however some researchers elect to use research staff within their departments working in concert with CTO to provide umbrella oversight. The major functions of the CTRC CTO are to: Facilitate timely activation and administration of clinical trials, including preparations and communications required for scientific, ethical, operations and logistics reviews • Ensure the research team is adequately trained to support each trial • Maintain a centralized web-based repository of all protocol specific documents and consents Provide clinical assistance to facilitate the conduct of clinical trials including but not limited to enrollment and verification of patient eligibility, scheduling of appropriate tests, treatments, and assessments • Provide data management support for clinical trials The QAD is separate from the CTO to minimize conflicts. Working with the DSMC, the functions of the QAD are to: Ensure that all reports, including reports of serious adverse events and unanticipated problems, are submitted in accordance with appropriate guidelines. Ensure protocol compliance with institutional policies and agreements, state and federal regulations, data accuracy and data integrity through a system of monitoring and quality assurance Provide training and education regarding best practices in conducting clinical trials to investigators and staff.