The mission of the NRG Oncology Statistics and Data Management Center (SDMC) is to provide all necessary expertise and personnel for the design, conduct and analysis of clinical trials and associated research for NRG Oncology, a member group of the NCI National Clinical Trials Network (NCTN) program. The Data Management Core of the SDMC provides the expertise to develop software, data collection mechanisms, database storage, and data management processes for state of the art clinical conduct, and to implement these tools and methods to manage the NRG Oncology clinical trial portfolio. The 2019-2024 cycle represents the second period of the NCTN program, which succeeded the NCI Cancer Cooperative Group program, of which NRG Oncology was formed by the unification of three existing Cooperative Groups. During the first cycle of the NCTN, the NRG Oncology SDMC has expended significant effort harmonizing data management and information technology practices in order to successfully transform into a united entity operating under common procedures and using the Medidata Rave database system. While maintaining a geographically distributed model, the Data Management Core now operates as a single highly efficient and productive unit, as evidenced by the successful initiation of 32 new trials and final approval on an additional 14 trials now in development, while continuing to maintain accrual and/or follow-up to primary and secondary endpoint reporting on over 80 additional trials that were active at the inception of NRG Oncology. Publications from the group in the first cycle number well over 300. In this second NCTN cycle, the Data Management Core will build on early success and continue to deliver comprehensive support for NRG Oncology clinical trials and related research, as well as support the additional information technology needs of the NRG Operations Center. Specifically, the Core will coordinate all study design and process decisions in collaboration with personnel from Data Management, Quality Assurance, Statistics, Information Technology, Protocol Development, and Imaging Technology. The Core will continue to advance the use of Rave functionality, including edit checks, query management, study calendar implementation, automated email alerts, import of imaging data, and reporting functions. The Core will conduct systems analysis of protocol data collection, review, and reporting requirements, extending Rave intrinsic functionality through custom programming, and develop additional data management tools for the web environment. The Core will provide comprehensive data quality control to assure data timeliness, accuracy, and validity. Finally, in information technology, the Core will continue to provide systems analysis, project management, and software development to support data management, statistical, and reporting needs for both the SDMC and the NRG Oncology Operations Office, and participate in NCTN working groups to support NCTN initiatives through systems analysis, code sharing, and the expansion of web services.
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