Clinical Protocol and Data Management

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Project Summary/Abstract: Clinical Protocol and Data Management (CPDM) The Office for Cancer Clinical Research (OCCR), previously referred to as the Centralized Protocol Data Management Unit (CPDMU), is the centralized office that supports clinical cancer research in the Fred and Pamela Buffett Cancer Center (FPBCC) at the University of Nebraska Medical Center (UNMC). The OCCR 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 OCCR 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 OCCR 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 OCCR is a resource within the FPBCC to provide investigators support for all cancer-related clinical research. It is composed of disease-oriented teams (DOT'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 OCCR provides investigators with support and study data management, as well as protocol development, monitoring for cooperative group studies, and liaison with federal and industry sponsors and regulatory bodies. The OCCR provides resource support to the FPBCC Scientific Review Committee (SRC), the Data Safety Monitoring Committee (DSMC), and the Audit Committee (AC). The OCCR manages the clinical trials management system (CPDM database) which houses protocol data necessary for planning, reporting and internal oversight, as well as eCRF development and study data reporting in C3D and MediData RAVE. The FPBCC OCCR has been active in NCI initiatives regarding the Clinical Trial Reporting Program (CTRP) and has been an early adopter of C3D and Medidata Rave.