Clinical Protocol and Data Management

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PROJECT SUMMARY: CLINICAL PROTOCOL AND DATA MANAGEMENT The Fred & Pamela Buffett (BCC) Clinical Trials Office (CTO), previously referred to as the Centralized Protocol Data Management Unit (CPDMU), is the centralized office which supports clinical cancer research in the Cancer Center. The BCC CTO provides centralized support for investigator-initiated trials (IIT), NCI National Clinical Trials Network and cooperative group trials (Main Member of Alliance, Children's Oncology Group, NRG) multi-institutional consortium trials (BIG10 Cancer Consortium, ACCRU) and industry-sponsored studies. The mission of the BCC CTO is to assist with the planning, development, conduct, quality assurance, monitoring and compliance of with regulatory agency requirements for clinical trials involving cancer treatments and care, and to provide regulatory support for cancer-related population science studies as well. The BCC CTO assures the highest quality of research and adherence to relevant regulations by primary upfront coordination of the study and ongoing review of research compliance. The BCC CTO is the resource within the Cancer Center, which provides support to investigators for all cancer clinical research. It is organized by disease-focused teams (DFT's) that coordinate study management activities, including screening subjects; coordination of treatment and care; and collecting and recording study data; as well as the regulatory management teams responsible for submitting and maintaining all regulatory documents and applications. The BCC CTO provides BCC investigators support for protocol development, data management, monitoring for cooperative group studies, and liaison with federal and industry sponsors and regulatory bodies. The BCC CTO also provides support to the BCC Scientific Review Committee (SRC), the Data Safety Monitoring Committee (DSMC), and the Audit Committee (AC). The BCC CTO manages the clinical trials management system (OnCore) which houses protocol data necessary for planning, reporting and internal oversight, as well as the development of electronic case report forms (eCRF) and study data reporting in Forte EDC (Electronic Data Capture). The BCC CTO has been active in NCI initiatives regarding Clinical Trial Reporting Program (CTRP).