CLINICAL PROTOCOL AND DATA MANAGEMENT: ABSTRACT Part I: Clinical Protocol and Data Management (CPDM): The Clinical Trials Office (CTO) serves as a centralized resource providing CPDM services and support to the Cancer Center with the highest priority being the safety of participating patients. The CTO provides comprehensive regulatory support from protocol conception to activation, including liaison and communication with the IRB of record and sponsors to facilitate timely initiation and completion of clinical trial activities, all approval and review processes with the IRB, IND support, registration of new trials with NCI CTRP and appropriate registration and results reporting with ClinicalTrials.gov. CPDM services facilitate and optimize accrual by providing centralized and trained data management and research nurse support to KCI physicians and clinical support staff. Research coordination and protocol compliance is enhanced through fostering of physician-patient-CTO interaction, collaboration and teamwork. The CTO interfaces with several Institutional Cores (Shared Resources) to facilitate and enhance collaboration, improve processes and ensure efficient and effective use of resources. The Clinical Trial Management System OnCore is utilized to administer all clinical trial requirements. CTO supports National Clinical Trials Network, NCI-funded peer reviewed, investigator-initiated, and industry sponsored protocols. KCI/WSU is a Lead Academic Participating Site under the NCTN (U10 CA180835). Over 100 FTEs provide CPDM services as members of the CTO in support of approximately 360 active protocols. Part II: Data and Safety Monitoring (DSM): DSM is required for all types of clinical protocols; monitoring is commensurate with risk and the DSM functions are distinct from the PRMS oversight and responsibilities. Effective quality control and training is provided by the CTO to ensure compliance to the Data and Safety Monitoring Plan (DSMP). This includes coordination and administrative support to the Feasibility Review and Operations Committee (FROC), Protocol Review and Monitoring Committee (PRMC), the Data and Safety Monitoring Committee (DSMC) and the Quality Assurance Committee (QAC). Part III: Inclusion of Women and Minorities: KCI maintains and supports multiple, proactive efforts to promote the recruitment of women and minorities. These efforts have resulted in exceptional enrollment of minorities and women to interventional trials over the current grant period with 40.2% accrual of minorities and 61.4% accrual of women in 2013. Part IV: Inclusion of Children: KCI partners with Children's Hospital of Michigan to facilitate pediatric accrual to clinical trials; supporting the NIH policy and guidelines on the inclusion of children in research.
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