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.
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