The Clinical Trials, Data Management, and Statistics (CTDMS) Core will provide the clinical coordination and data management for all patient-based experiments in the SCCOR, as well as the data management for all non-clinical experiments. This core will also provide the statistical expertise to interpret the data. The Core is comprised of three functional units: clinical coordination; data management; and statistics. These functions will be performed by the International Center for Health Outcomes and Innovation Research (InCHOIR), a university based clinical and data coordinating center that is a collaborative effort of the Mailman School of Public Health and the College of Physicians and Surgeons of Columbia University, New York. The CTDMS will provide several critical functions in the SCCOR studies: (1) Protocol Development. The Core investigators will be involved in the finalization of the protocols for all clinical studies and in the development of electronic Case Report Forms (eCRFs) and Operations Manuals. (2) Clinical Coordination. The Core will be in regular contact with the clinical centers to review patient enrollment, discuss recruitment strategies to ensure optimal enrollment of women and minority patients, assist the clinical investigators in drafting management guidelines, and review the management of SCCOR patients. (3) Data Management. The Core will provide a secure, validated, centralized electronic data management facility that is HIPAA and FDA-compliant. The Core will develop and maintain systems to enable direct data entry via the Web, provide automated patient randomization, time stamping, file archiving, data validation and reporting services, and a telephone help desk for technical support. (4) Site Management, Quality Assurance, and Monitoring. The Coordinating Core will train the clinical investigators in the specifics of the protocol, review the quality of the data, issue queries, monitor the sites on a regular basis to ensure data quality and integrity, and assist the Morbidity and Mortality Committee in adjudicating the data. (5) Statistical and Analytical Support. The Core will provide statistical design and analytical support to the final planning of the experiments, generate the randomized treatment assignments, perform the interim analyses for the Data Safety and Monitoring Board (DSMB), perform the final analyses, and participate in the preparation of study presentations and manuscripts.
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