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OPERATIONS

Rutgers University, Center for Emerging Pathogens hosts the Data and Operations Management Center (DOMC), dedicated to the operations and conduct of sponsored clinical studies. The DOMC currently coordinates and manages 12 NIH-sponsored UO1 and RO1 projects, involving human prospective clinical studies in eleven (11) TB-endemic countries, involving adult, pediatric, MDR-TB in biomarker discovery, diagnostic testing evaluation and epidemiology/genomics. The DMC has extensive experience as the Data, Administrative, Operations Management Center for TB CDRC (2009-2016), TB Research Unit (2014-2021), FEND-TB (2020-2025), TB-RePORT International Coordinating Center (2021-2023) and ICIDR programs in activities of biomarker discovery, POC TB diagnostics evaluation, including: design/development of case report forms, data entry/ management; operational implementation; quality assurance; statistical analysis; maintenance of study data, documentation and regulatory compliance. Twelve staff at the center include clinical coordination, biostatistical analysis, laboratory QA/QC coordination, data capture/data management, regulatory coordination and biorepository management.

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For the FEND for TB program:

  • Clinical Data Collection: Study data is collected using REDCap (Research Electronic Data Capture, Vanderbilt University) tools hosted by Rutgers University. REDCap has the features required for 21 CFR Part 11, FISMA, and HIPAA-compliance, and provides a secure, web-based application allowing for 1) validated data entry; 2) audit trails of all data entry, manipulation, and export; 3) customizable reports and exports to all common statistical packages; 4) tools for seamless data import and 5) customizable user access permissions. REDCap allows for direct on- or off-line electronic data capture via Android-based hand-held tablets with VPN secure-Wi-Fi for clinic-based data capture during participant interviews, and study-specific computers for capture of clinical and laboratory results/information. 21 CRF Part 11 compliant and administrative controls have been established by Rutgers as the REDCap consortium partner host institution. Data uploaded from tablets to project desktops and uploaded to the REDCap server or HIPAA-compliant secure box.com.

  • Database Management: DOMC exports REDCap collected data into interim Access databases for review, query and resolution per SOP and GCP guidelines. Data interns, study coordinator works with site teams to establish valid and complete data for statistical analyses. All data remains deidentified with Study ID numbers for CRFs, specimen and query use. Final databases using SAS or R computing relational database programs are used for analysis and shared with biostatisticians/informatics specialists via box.com. Files will be stored on Rutgers shared drives maintained by Rutgers University IT group, with routine backup and SOPs for disaster prevention and recovery. Mirror working databases (Access) and REDcap accounts are used by the site teams to use for routine review and progress reports. Routine clinical/laboratory audits to meet GCP (ICH-GCP (E6)) and GLP and submit reports to PIs following audit. FEND-TB Clinical Core Coordinator will visit clinical sites on a regular basis or for cause to insure GCP, GLP, and approved protocol compliance.

  • Biorepository Management: DOMC utilizes FreezerPro Cloud, a web-based samples management solution (Chelmsford, MA) that the DOMC has successfully used since 2012 for ICIDR, TBRU and RePORT-India specimen storage. This platform is extended into the proposed clinical sites employs a specimen tracking system using QR code technology for specimen accession, labeling and tracking. FreezerPro Cloud is a sample tracking solution to manage biospecimens across institutions. Creation of virtual freezers assists with management and identifies source vials by “pull lists” when needed for analysis or to digitally accompany shipments to other laboratories. FEND-TB sites adhere to GCP and GLP in the secure storage of participant samples, either in liquid nitrogen or -80°C freezers at their labs. A complete annotation of samples and aliquots consistent with the workflow of specimen processing allows for searching in the web-based databases by authorized users on-site or across FEND-TB institutions.