Clinical Protocol and Data Management

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CLINICAL PROTOCOL AND DATA MANAGEMENT PROJECT SUMMARY/ ABSTRACT The Winship Clinical Protocol and Data Management (CPDM) unit provides the infrastructure for clinical research conducted at Winship. CPDM has three main objectives: supporting the safe and ethical conduct of clinical research; promoting the generation of high quality data; and increasing access to clinical trials for subjects in the Winship catchment area, with an emphasis on underrepresented populations. CPDM includes the Winship Clinical Trials Office (CTO), clinical data management team, regulatory specialists, quality assurance team (QAT), and the Data Safety and Monitoring Committee (DSMC). The CTO provides the infrastructure for all aspects of trial conduct including design, regulatory processes, activation, conduct, data collection, and analysis. The CTO also provides training and education in clinical research for Winship members and staff. The clinical data management team and the regulatory specialists are organized in cancer disease site-based teams. Teams have dual reporting to the physician leaders of the respective disease site-based teams and to the CTO assistant directors. The CTO has a specialized team focused on the conduct of multi-institutional trials for which Winship investigators serve as PI's. This team coordinates trial conduct and provides on-site or remote monitoring of participating institutions. The Winship trial portfolio has an intentional distribution of institutional, industry- sponsored, externally peer-reviewed, and NCI-supported National Clinical Trials Network (NCTN) trials. The QAT coordinators audit institutional and NCTN trials in real time to ensure compliance. The DSMC oversees the implementation of the Winship data safety and monitoring plan. The primary focus of the DSMC is to ensure the highest level of compliance in the institutional, NCI-funded, and NCTN trials. Recent analyses of trends of measurable outputs reveal significant improvements in key measures of Winship clinical trial conduct including accrual to trials, reduced trial activation times, and compliance with study protocol requirements. During the present funding period, Winship has developed new research-related standard operating protocols (SOP), improved staffing of the CTO to meet the growth in clinical trials accrual, and implemented clinical trials data management software. A software solution for biospecimen tracking and another software system for radiologic response evaluation have been implemented during the current funding period. During the next funding period, Winship will increase patient accrual to clinical trials with an emphasis on the affiliated Winship facilities, develop stronger clinical research infrastructure at those sites, increase underserved populations' access to clinical trials, increase clinical trial access within the Winship Cancer Network, and improve clinical trials informatics platforms.