Project Summary/Abstract – Data Management Core A well-functioning Data Management Core (DMC) is essential to the success of the UCI Vaccines for Pandemic Preparedness Center (VPPC). DMC provides shared informatics infrastructures and rigid data integrity oversight that are key to the quality, efficiency, and cost-effectiveness of VPPC’s data generation and management processes. DMC also plays an indispensable role in ensuring all digital assets created by VPPC conform fully to the Findability, Accessibility, Interoperability, and Reusability (FAIR) guiding principles so they can be readily shared with the scientific community to accelerate discovery and results translation. Such digital assets include not only the data generated by the Center, but also the associated metadata, documentation, and algorithms and software code. The UCI VPPC DMC, described in this proposal, is committed to working with all VPPC Scientific Cores and Research Projects to implement a consortium-wide Strategy for Management of Data Activities Plan and operationalize the strategy through the establishment of data policies, shared informatics infrastructures, and standard operating procedures (SOP). DMC will also develop automated data transformation and quality control pipelines to minimize errors and maximize conformity to the data and interoperability standards specified by the ReVAMPP Coordinating and Data Sharing Center (CDSC). We will work closely with CDSC to ensure high- quality and timely transfer of data to the ReVAMPP Network, as well as collate information to promptly respond to inquiries from CDSC or NIAID program staff regarding the Center’s compliance with network-wide timelines and network data sharing policies. The work to be performed by DMC will largely leverage UCI’s existing research computing resources to reduce redundancy, improve cost-effectiveness, and enable centralized data management and oversight. We will assist each Scientific Core and Research Project in designing custom informatics solutions optimized for their data storage and computing needs. We will coordinate with the Administrative Core to deploy software systems to facilitate consortium-wide project management, and with the Regulatory Science Core to implement the regulatory-enabling Total Quality Management System (TQMS) at each step of the data lifecycle (i.e., acquisition, transformation, storage, analysis, sharing, and archiving) to improve regulatory readiness of our vaccine candidates to enable rapid response, approval, and deployment. The proposed DMC activities will be organized under the following 3 specific aims—Aim 1: To provide shared informatics infrastructures to facilitate centralized management of all data activities of VPPC; Aim 2: To implement standard operating procedures and automated data transformation and quality control pipelines to ensure data integrity and regulatory readiness; and Aim 3: To enforce conformity to data and interoperability standards specifie...