CLINICAL TRIALS SHARED RESOURCE

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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.