CCSG COMPONENT 003 ? CLINICAL PROTOCOL AND DATA MANAGEMENT PROJECT SUMMARY/ABSTRACT The Vanderbilt-Ingram Cancer Center (VICC) Clinical and Protocol Data Management team (CPDM), known internally as the VICC Clinical Trials Office (CTO), provides investigators conducting translational and clinical investigators with the infrastructure necessary to conduct scientifically meritorious research on a local and national level. CPDM services are available to all Vanderbilt investigators conducting cancer-relevant trials. The CTO is operationally organized by Disease Team (DT) and provides regulatory and data management services, research nursing support, as well as contract and budget negotiation, quality assurance, data and safety monitoring and multi-center investigator-initiated trial (IIT) development programs. VICC places the highest priority on the safety of patients participating in research trials and continually strives to foster and maintain the highest level of oversight and compliance across the clinical and research enterprise. As a result of this long- standing commitment to research excellence, every interventional trial conducted at VICC must include a plan for data and safety monitoring. The NCI-approved VICC Data and Safety Monitoring Plan (DSMP), was revised and approved by the NCI in 2019. The plan outlines that while each PI is responsible for day to day oversight of their protocol, the initial scientific review conducted by the VICC SRC includes the assignment of a more detailed, protocol-specific plan for DSMC oversight based on the DSMP. Per the plan, the DSMC is independent of the SRC and has the right to modify the SRC recommendations within the parameters of the DSMP. Since the last reporting period, the CTO has made continuous process improvements and expansions within several service lines to adapt to the increasing complexity of cancer trials while developing new workflows to capitalize on opportunities provided by the Epic transition. The results of these changes are anticipated to reduce trial opening times and improve ability of investigators to meet accrual goals moving forward. During the project period, the total number of protocols managed by the CTO has increased by 27%. Among the trials conducted at VICC in CY18, 118 of the 452 (26%) protocols open to accrual were were initiated or significantly influenced by VICC investigators, even when sponsored by industry partners. Importantly, VICC investigators have enrolled 492 patients to National Group studies during the project period. VICC is committed to providing or supporting excellent care and access to trials for the catchment area and ensuring the appropriate representation of women, minorities and children as well as offer the mix of trial targeting underserved populations in the catchment area including Blacks and Latinos and socioeconomically disadvantaged populations. The CTO will continue to respond to and support the needs of its investigators by adapting its processes and workflows as the landscape of research advances, and remains committed to cancer prevention and improving outcomes for cancer patients.
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