CLINICAL TRIALS SHARED RESOURCE

项目总结 Winship癌症研究所临床试验办公室(Winship CTO)是Winship癌症研究所的共享资源，通过提供资源的集中管理和支持来支持临床研究，以进行涉及癌症患者的高质量临床试验。 Winship CTO管理临床试验实施的整个流程，包括涉及癌症患者的临床研究研究的受试者筛选、同意、注册、数据输入和监管文件提交。这是通过实现以下六个目标来实现的： 1.为制定和实施与癌症相关的人类临床研究方案提供基础设施支持。 2.向疾病管理小组提供行政支助，以促进受试者筛选、同意、登记、特定研究的测试和治疗、反应和毒性评估以及数据输入。 3.为癌症疾病现场团队提供监管支持，以确保遵守良好的临床实践、IRB、FDA和其他监管机构。 4.监测治疗性和非治疗性癌症相关临床试验受试者的总体应计费用，并在监测特定方案的应计费用方面为Winship执行董事和研究计划负责人提供支持。 5.为参与临床研究的教职员提供教育和培训。 6.向埃默里社区和佐治亚州的患者和转诊医生传播涉及癌症患者的积极临床试验的信息。

PROJECT SUMMARY The Winship Cancer Institute Clinical Trials Office (Winship CTO) is a shared resource of the Winship Cancer Institute that supports clinical research by providing centralized management and support of resources to conduct high-quality clinical trials involving cancer patients. The Winship CTO manages the overall process of clinical trial conduction, including subject screening, consent, registration, data entry, and regulatory document submission for clinical research studies involving cancer patients. This is accomplished by fulfilling the following six objectives: 1. To provide infrastructure support for the development and implementation of human clinical research protocols relevant to cancer. 2. To provide the disease management teams with administrative support to facilitate subject screening, consent, registration, study-specific tests and treatments, response and toxicity assessment, and data entry. 3. To provide the cancer disease-site teams with regulatory support to ensure compliance with Good Clinical Practice, the IRB, FDA, and other regulatory agencies. 4. To monitor overall accrual of subjects on therapeutic and non-therapeutic cancer-related clinical trials and provide support for the Winship Executive Director and leaders of the research programs in monitoring accrual to specific protocols. 5. To provide education and training for staff and faculty involved in clinical research. 6. To disseminate information on active clinical trials involving cancer patients to the Emory community and patients and referring physicians in Georgia.